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Thursday, August 25, 2016

Deputy General Manager - Quality Assurance

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Job Description

Location Ahmedabad 

Designation Deputy General Manager QA 

Role

1. Overall In charge for OSD Total Quality management system for all operations having an impact on quality of the process and final product.
2. Responsible for coordination and compliance for various regulatory inspections.
3. Responsible for the review and approval of plant documentation, compilation for submission to regulatory requirements.
4. Responsible to coordinate the plant management quality review meetings and Site transfer of technology.
5. Responsible for assessment and final approval of all Change Controls and monitoring of changes.
6. Responsible for the final approval of the product for dispatch after reviewing all the quality records. (Batch Manufacturing and packing Records, In -process Quality Control records, COAs, and other related batch records like deviation/investigation reports).
7. Responsible for the coordination of the cGMP and on the job training of the plant personnel.
8. Responsible for the initiation, review and assessment and final approval of deviations, non -conformances, Out of specifications.
9. Responsible for monitoring of all quality related activities and for the review and approval of Annual product quality review documents.
10. Responsible for the approval of the standard operating procedures, standard testing procedures, General Testing Procedures, Validation protocols, Master Formula Records, batch records (BMR,/BPR) and all other Master documents viz., Site Master File, Validation Master Plan, Training Manual and Quality Manual .
11. Responsible for total documentation control through proper change control system.1
12. Responsible for the approval of investigation and findings of market complaints.
13. Responsible for the coordination incase of product recalls.
14. Responsible for the GMP monitoring in the plant and approval of self -inspection reports.
15. Responsible for the timely updating of the documents in line with the current regulatory guidelines.
16. Co -ordination with QC, packaging development and marketing departments for generation and approval of artwork.
17. Responsible to review and Approve the technical Agreements.
18. Responsible for the identification of Crisis situation, act accordingly and ensure compliance.
19. Periodic assessment of the vendors through vendor audit and vendor approval.
20. Plant operations in monitoring and control of manufacturing environment, plant Hygiene and GMP compliance in the plant.
21. Joint responsible with QC in assessment and conclusion of stability studies.
22. To manage and face Regulated Audits like US -FDA / MHRA / WHO -Geneva / TGA / EU

Education Background

M.Pharm / B.Pharm /M.Sc graduates with 12 years experience in Quality Assurance functions for pharmaceutical formulations, experienced in facing regulated market audits like US -FDA / MHRA / WHO -Geneva / TGA / EU etc. 


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Monday, September 14, 2015

Urgent - Housekeeping Officer @ Fortis Hospital, Mulund, Mumbai by pharmanaukri.in


Job Description
Reporting to Head Non-Medical Services on a day-to-day basis.
Taking rounds of the property (Individual/with Manager & with Supervisors in a day).
Assistance in making schedule for supervisors for all departments & briefing them about any changes in the systems.
Interacting with patient /relatives.
Preparing training schedule for Housekeeping department & others.
Following setup of all Conferences & ensuring smooth working.
Co-ordination with Maintenance Dept. for the Snag lists.
Co-ordination with linen dept.
Interaction with nursing supervisors/ Superintendent.
Co-ordination with all vendors.
Tracking MIS.
Support to senior level management.
Overlook for the effective and efficient performance of assigned personnel.
Ensuring facility maintains a positive image.
Preparing new format of check lists.
Record keeping and over looks legal documents in case of any discrepancy.


Salary: INR 4,00,000 - 5,00,000 P.A
Industry: Medical / Healthcare / Hospitals
Functional Area: Other
Role Category: Other
Role: Other
Keyskills: housekeeping
Desired Profile

Education:UG -Any Graduate - Any Specialization 
PG - Post Graduation Not Required 
Doctorate - Doctorate Not Required
Company Profile
Fortis Healthcare Limited is committed to clinical excellence and patient-centric healthcare, which is manifest in hospital design, patient services, medical programmes and the compassionate approach of medical and non-medical hospital staff. Fortis commissioned its first hospital in 2001 at Mohali, near Chandigarh, and has expanded its operations to become a network with an over 10,000 bed capacity across 68 hospitals
Contact Details
Recruiter Name:Neelam Thakur / Abhishek Jadhav
Contact Company:Fortis Healthcare Ltd
Telephone:022-49254263
Email :resumes.mulund@fortishealthcare.com

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Pharmacist@ Fortis, Cunningham Road Bangalore by pharmanaukri.in



Job Description

    To make the drugs available to both in patients and out patients 
    To make sure that all the legal and safety protocols are observed
    To make sure that right drugs are dispensed
    To contribute in the increase of turn over and profits


    MANDATORY: KARNATAKA PHARMA COUNCIL REGISTRATION
Salary:Not Disclosed by Recruiter
Industry:Medical / Healthcare / Hospitals
Role Category:Medical Professional
Role:Pharmacist/Chemist/Bio Chemist


Desired Candidate Profile

Education-
UG:B.Pharma - Pharmacy, Diploma
PG:Post Graduation Not Required
Doctorate:Doctorate Not Required
    Please refer to the Job description above
Company Profile:
Fortis Healthcare Ltd

Fortis Healthcare Limited is committed to clinical excellence and patient-centric healthcare, which is manifest in hospital design, patient services, medical programmes and the compassionate approach of medical and non-medical hospital staff. Fortis commissioned its first hospital in 2001 at Mohali, near Chandigarh, and has expanded its operations to become a network with an over 10,000 bed capacity across 68 hospitals

Recruiter Name:Rakesh
Email Address:
Telephone:080-41994493


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Opening for Patient Care Services or Receptionist by pharmanaukri.in



Job Description
New Registration, counseling for chargeability, admission for regular cash paying patients , ECHS & other Corporate patients
Completion of corporate documentations & Escorting to their respective wards. 
Processing & Update the Corporate (excel) file both on paper and in the module, communicating through mail to respective HODs regarding., Staff Admission, Staff Dependants, Beas, VIP pt
Issue Calling Code to the pt. attendants so that they can call out side from the hospital
Counseling and Admissions (including Upgrade Surgeries)
Visitor passes. Codes & update the Calling Code (excel) file and for activation mail to IT helpdesk & team leader
Doctor change request in case pt. need to shift in another specialty Up gradation of Remarks for any kind of message
Guest queries & Room Booking for expected admissions for next few days
Follow up for daily payable report while issuing the temp. Passes and updating the remarks
Handling Billing queries for routine pt. attendants
Taking request from Nursing Station or from the attendants for the particulars & Address Change Request
Informing attendants (by announcement / calls on cells
Request for Package Detail (Reimbursement request) in case pt. is Govt. Employee and required package breakup
Cash Collection / Refunds Issuance of Receipts against deposits
Issuance of Clearances (For Surgeries, Upgraded Surgeries & Final Discharges)
Inform Telephonically to the respective wards and direct call to the attendants about the discharges on receiving bill. So that they will clear the dues and take final clearance.
Appointment, admission and discharge of patients : Billing, generate invoices, maintain daily scrolls, provide Cash/ Credit/ Corporate billing and discount information to customers
Registration: Complete the registration process in a timely and accurate manner
Cashiering: Submit deposited cash/ cheque/ drafts/ credit slips to finance. Hold Responsibility for short cash, fake currency and opening and closing of shift
MIS: Maintain and generate process related data as and when required by the HOD
Preventive Health Check: Coordinate smooth and timely flow of PHC patients, follow up of their reports & post check up consultation as per patients convenience
TPA: Provide a seamless and trouble free experience in getting cashless treatment. Follow up with various TPAs/ corporates about status of payment. Update patients and doctors about status of authorization
Provide patients with information regarding advised investigations and procedures
Assist and direct patients that have come in for health check up 
Manage and record time spent by patient as mentioned in the standard operating procedure
Co-ordinate for timely delivery of the report at the designated counter
Maintain service standards as specified in the standard operating procedure
Diligently adhere to patient flow-chart and highlight any process related issue to shift supervisor and HOD on shift basis
Interface with SRL Ranbaxy Lab and other diagnostic areas for patients investigation reports
Uphold basic standards of cleanliness of work place area as well as self-grooming, and demonstrate use of standard phrases and telephone etiquette during all points of customer interface 
Proactively distribute feedback forms and seek suggestions from patients/attendants 
Possess comprehensive knowledge of all HIS applications, all instructional manuals and operating procedures applicable to the job profile
Effectively utilize all communication systems
Adhere and contribute to cordial inter and intra team relations
Complete any other ad-hoc task assigned by the concerned superior



Salary: Not Disclosed by Recruiter
Industry: Medical / Healthcare / Hospitals
Functional Area: Executive Assistant, Front Office, Data Entry
Role Category: Receptionist
Role: Receptionist
Keyskills: Admissions, Patient Care, front office, front desk, receptionist, reception, fro
Desired Profile

Education:UG -Any Graduate - Any Specialization 
PG - Post Graduation Not Required 
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
Fortis Healthcare Limited is committed to clinical excellence and patient-centric healthcare, which is manifest in hospital design, patient services, medical programmes and the compassionate approach of medical and non-medical hospital staff. Fortis commissioned its first hospital in 2001 at Mohali, near Chandigarh, and has expanded its operations to become a network with an over 10,000 bed capacity across 68 hospitals
Contact Details
Recruiter Name:Jessy John
Contact Company:Fortis Healthcare Ltd
Telephone:Not Mentioned

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Saturday, September 12, 2015

Senior Statistical Programmer PAREXEL International Corporation by pharmanaukri.in

Job Description
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required.
Qualifications
Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:

Input into and negotiate statistical programming timelines; ensure that timelines are adhered to
Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
Monitor project resourcing, project budgets, and identify changes in scope
Interact with Sponsors as the key contact with regard to statistical programming issues
Provide technical support and advice to the internal team
Check own work in an ongoing way to ensure first-time quality
Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed
Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation
Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents
Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department
Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units
Create standard macros and applications to improve the efficiency of the department
Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
Be trained in sponsor WSOPs and disseminate knowledge to project team members as appropriate
Proactively participate in and/or lead process/quality improvement initiatives
Work closely with the Quality Management Groups (QMG) to ensure compliance with
WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas
Maintain and expand local and international regulatory knowledge within the clinical industry
Assist project teams in the resolution of problems encountered in the conduct of their daily work
Provide relevant training and mentorship to staff and project teams

Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Analytics & Business Intelligence
Role Category: Data Analyst
Role: Data Analyst
Keyskills: SAS, Statistical Programming, Macros, Clinical Trials, Biostatistics, QC, Quality Management, Process Quality, Quality Improvement, Quality Standards, Data Analyst
Desired Profile
 
Education:UG -Any Graduate - Any Specialization 
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required 
Doctorate - Doctorate Not Required
Company Profile
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.

Contact Details
Recruiter Name:Not Mentioned
Contact Company:PAREXEL International (India) Pvt Ltd
Telephone:Not Mentioned
Reference Id:post-00022834

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Dr. Reddy's - Walk-in Drive for QC, QA and Production for Injectables - 30 Opening(s) by www.pharmanaukri.in


Walk-in DetailsDate-13th September, Starting Time: 9 AM
DesignationDr. Reddy's - Walk-in Drive for QC, QA and Production for Injectables - 30 Opening(s)
Job DescriptionDr. Reddy's Laboratories Ltd. -  Walk-in Drive for QC, QA and Production for Injectables units based at Vishakapatnam 13th Sept, 2105

Candidates matching below criteria can Walk-in directly with their updated resume and latest increment letter.

Venue: Hotel Lemon Tree, Indore

Contact person: Mr. Kaushik, Human Resources

Function: Quality Control

Experience: 2 - 6 years

B.Sc / M.Sc /B. Pharm with 2-12 years of relevant experience in Formulations (In Process and Finished Product Analysis, Microbiology, RMPM Analysis, Stability Analysis, calibration and qualification of instruments) 

Aggregate of 60 % marks in their highest qualification is mandatory for all the above positions.

Note: candidates with M. Pharm need not apply.

For QA Function:

Qualification:  B. Pharm, M. Pharm, M. Sc

Experience:  2 to 8 years in IPQA, Analytical Assurance, Engineering Assurance, CSV, Qualifications and Validations.

Production:

Qualification:  B. Pharm/D. Pharm

Experience: 2 to 6 years of experience in Injectables manufacturing, Lyo, Lypholisation, PFS, SVP, LVP, Optamalic, Filling, Dry Power Injectables, Liquid Injectables, Injectable compounding, Injectable component preparation, Autoclave
Desired ProfilePlease refer to the Job description above
Experience2 - 7 Years
Industry TypePharma / Biotech / Clinical Research
RoleQuality Assurance/Quality Control Executive
Functional AreaProduction, Manufacturing, Maintenance
Education
UG - B.Sc, B.Pharma
PG - M.Sc - Any Specialization, Physics, Any Specialization, Physics, M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Compensation: Not disclosed
LocationHyderabad / Secunderabad, Visakhapatnam/Vizag
KeywordsQuality Control quality analyst testing qc quality assurance IPQA IPFP Stability Calibration Analytical assurance CSV Validatiion production manufacturing packing
ContactDr. Reddy's Recruitment Team 
Dr Reddys Laboratories Ltd 
Telephone0000000000
Websitehttp://www.drreddys.com
Job Posted2015-09-10 14:11:24.0
ReferenceWALKIN Indore

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Executive - Regulatory Affairs Piramal Enterprises - Healthcare by pharmanaukri.in

DesignationExecutive - Regulatory Affairs
Job DescriptionPreparation and compilation of regulatory documents (DMFs / ASMFs) for filing with regulatory agencies and customers. Communication with concerned internal customers to address the technical queries on the dossiers and other regulatory submissions, including marketing related queries. Filling the customer questionnaires, adherence to QA systems and IT policies related to the electronic submissions (DMFs, ASMFs & SPLs) through ESG. Internal audits for regulatory compliance. Updating and organising with Pharmacopeia revisions, track record (electronic & paper) for all registered products. cGMP training-planning, and adequacy of the training. Monthly reports for RA activities.
Desired Profile
S/he should have good exposure in CFR Part-11 compliances,
ICH guidelines, Pharmacoepias, Audit trial reviews and
maintenance, investigations, deviation handling etc.

S/he should be capable of handling shifts independely and should be willing to reallocate in Zaheerabad


Experience2 - 3 Years
Industry TypePharma / Biotech / Clinical Research
RoleOther
Functional AreaOther
EducationUG - B.Sc - Microbiology
PG - M.Sc - Microbiology
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Compensation: 3,00,000 - 4,00,000 P.A. Free transportation facility from plant to Zaheerabad, Subsidised Canteen, GPA, Medical Insurance for Self + 5 dependants, etc.
LocationHyderabad / Secunderabad
KeywordsRegulatory Affairs RA eCTd Compliance ectd regulatory GMP Compliance
ContactHR 
Websitehttp://www.piramal.com
Job Posted2015-09-12 17:24:43.0
ReferenceDig/QC/Micro/B1/150225


Apply

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www.pharmanaukri.in a unique website for pharmaceutical jobs in India


www.pharmanaukri.in is one of fast growing unique website for pharmaceutical jobs in India.
pharmanaukri.in established from blogger platform to serve the daily openings information to the country. We are proud to be in place to keep the daily trends


-Mahender Nagaraju



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