Monday, August 29, 2016

Sr. Executive / Executive/Research Associate/Manager Formulation Development - NDDS /Regulatory Affairs/Quality Control

Image result for intaspharma.com logo

SrPosition / DesignationDepartmentNo. of
Opening
Location

1ManagerCQA

  • Implementation of Vendor Management System
  • Maintaining Vendor schedules and documents
  • Candidate should have Bulk Drugs / API facility experience
  • Should have experience of API / SM / Excipient Vendor Audit

hrd_matoda@intaspharma.com
2Matoda PlantClick to View
2Sr. Executive / ExecutiveCQA

  • Candidate should have Bulk Drugs / API facility experience
  • Should have experience of API / SM / Excipient Vendor Audit
hrd_matoda@intaspharma.com
1Matoda PlantClick to View
3Research AssociateFormulation Development - NDDS
  • Candidate should have experience in NDDS Product Development of Parenteral, Solid oral and Semi solid dosage forms for Regulated and Domestic Markets
  • Execution of Scale-up and Clinical Trial Batches for NDDS projects. Candidate should be competent for troubleshooting of the allotted projects
  • Responsible for exhibit / validation batches in co-ordination with process development lab
  • Should care for documentation and compilation of necessary regulatory submission data
  • Should have experience in technology transfer from R&D to manufacturing site
  • Monitoring stability of products during development and validation batches
  • Should co-ordinate with various functions like Analytical, QA, PDL & Plant etc.
sdwivedi@intaspharma.com
1AstronClick to View
4Senior Research ScientistRegulatory Affairs
  • Can initiate to collect, review & archive all technical information related to product registration for oral solid products in the Europe market. Person can take responsibility to coordinate with team members for dossier compilation, query responses activity and care of the assigned products for the EU countries
  • Acquaint the filling requirements for the veterinary oral solid drug products in the Europe market
  • Capable to provide the regulatory support to the various departments and regulatory system up gradation in context with the new regulatory requirements with respect to EU filling
  • Carry out activities associated with installing the dossier on web and its access by clients
  • Carry out additional activities related to the regulatory department as and when required
sdwivedi@intaspharma.com
3AstronClick to View
5Research AssociateR&D
  • Downstream Process Development and Protein Purification for Microbial and Mammalian Products
  • Understanding of Process characterization and QbD approach
  • Provide technical support for designing experiments and facilitating technology transfer activity to manufacturing
personnel_biotech@intaspharma.com
1BiopharmaClick to View
6Officer / Sr. Officer / ExecutiveQuality Control

  • Should be well-versed with operation of sophisticated instruments like HPLC, GC, AAS & UV Spectrophotometer
  • Should possess knowledge of GLP, GDP and various regulatory procedures
  • To perform method validation / method transfer
  • Knowledge of SAP will be an added advantage
prasenjit_das@intaspharma.com
4SEZClick to View


Send cv to:

hrd_matoda@intaspharma.com



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Manager CQA at Intas

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Position / DesignationDepartmentNo. of
Opening
LocationJob DescriptionSend your latest resume to
1ManagerCQA2Matoda Plant
hrd_matoda@intaspharma.com

Job Description for Manager
Required Experience : 4 to 7 years
Education Qualification : B.Sc. / M.Sc. / B.Pharm. / M.Pharm.
Job Profile :
  • Implementation of Vendor Management System
  • Maintaining Vendor schedules and documents
  • Candidate should have Bulk Drugs / API facility experience
  • Should have experience of API / SM / Excipient Vendor Audit




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Executive QA by innovative placements

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Regulatory Affairs (submission / Publishing / Product Licensing / LCM)

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    IPMS Placements Private Limited hiring for Multinational Pharmaceutical Company

    Job Description

    Person having experience in RA US & Europe Market Formulation. Submission Management, Publishing, Annual Reports, LCM, Product Licensing. Different position for each category. Chennai Location.
Salary:INR Open
Industry:Pharma / Biotech / Clinical Research
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager


Desired Candidate Profile

Education-
UG:Any Graduate - Any Specialization, B.Sc - Any Specialization, B.Pharma - Pharmacy
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required, M.Sc - Any Specialization, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
    Please refer to the Job description above
Company Profile:
IPMS Placements Private Limited

Multinational Pharmaceutical Company
Our Client is one of the most renowned American multinational pharmaceutical company. This position is for Chennai Location

Recruiter Name:Ms. Swagaika Senapati
Address:306, Opal Square, Behind Express HotelR C Dutta RoadAlkapuri,Gujarat,India 390007
Email Address:
Telephone:09687640799
Reference Id:swagatika@innovativeplacement.com


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Senior Statistician -SR Novartis Healthcare Pvt. Ltd. Hyderabad

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Job Description

    Responsible for leading and delivering statistical analytic solutions for multiple Phase I-IV clinical trials at a trial level by executing RAPs, ensuring high quality and timely production of statistical reporting deliverables (analysis datasets, tables, listings and graphs).

    Supervise CROs as required and ensure timely deliverables.

    Major Activities (Describe 8-12 main activities)

    1. Lead the statistical activities for a trial or publication activities.

    2. Responsible and accountable for transcribing RAPs into computational solutions for the statistical programmer to implement (specifications of derived variables, specification and development of statistical computing solutions for inferential statistical analyses, tables and listings templates for the FIR and CSR) of Phase I-IV clinical trials.

    3. Responsible and accountable for multiple studies RAP execution including the RAP meetings with the necessary CTT members and third party, reporting activities, exploratory analyses/ and additional analyses to support publications for individual clinical trials.

    4. Ensure high quality for all assigned deliverables and processes and ensure audit-readiness.

    5. Maintain efficient interfaces with internal and external customers with support of CTS management, Lead Statistician, CROs and CPOs as needed.

    6. Ensure to deliver agreed timelines for statistical deliverables.

    7. Develop and comply with project / study standards and specifications following internal guidelines.

    8. Provide statistical analysis solutions when exploratory analyses are required.

    9. Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.

    10. Participate in the selection of CROs and supervise the trial activities of the CROs as needed.

    11. Support quality control and quality audit of deliverables.

    12. Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH
Salary:Not Disclosed by Recruiter
Industry:Medical / Healthcare / Hospitals
Role Category:

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Statistical Programmers / Clinical SAS: Drive in Mumbai on 16 Sep 2016 Novartis Healthcare Pvt. Ltd.

Image result for Novartis LogoImage result for novartis hyderabad
Novartis Healthcare is hiring ...!

    Golden opportunity to meet us directly in Mumbai

    Job location  : Hyderabad.

    1.Statistical Programmer       -      3 - 5 Years
    2.Senior SAS Programmer    -      5 - 8 Years
    3.Lead / Principal SAS Programmer    -     8+ Years

    Job Description:Locally coordinate and take responsibility for trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to support program programmers and statistician in project level activities.
    Be responsible for statistical tasks on assigned clinical trials e.g. RAP.
    Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.
    Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
    Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones.
    In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
    Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
    Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH

Salary:INR 7,00,000 - 17,00,000 P.A
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical Healthcare R&D , Pharmaceuticals ,Biotechnology
Role Category:R&D
Role:Clinical Research Manager

    NOTE:   Only the shortlisted applications are invited for the drive

    Please share this email in your network, to help someone waiting for an opportunity to work with Novartis Health care.

    Reach me undersigned or drop me a note for more details.

    Regards
    Naresh Kumar.Gunda
    040-67581684.
    Naresh_Kumar.Gunda@Novartis.com

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Thursday, August 25, 2016

Deputy General Manager - Quality Assurance

Image result for zydus cadila products

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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