Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Wednesday, February 22, 2012

Manager Quality with US MNC Healthcare at Gurgaon



Job Description
Overall responsibility of all quality (QA/QC) aspects involved in manufacturing of pharmaceutical products through contract manufacturer.

1. Effectively maintain Quality Assurance and in process control system at contract manufacturing facilities as per Indian regulatory/internal international requirements.

2. Performing internal/external audits. Supporting regulatory audits.

3. In-process QA: assuring testing of intermediate product including bulk products, determination of batch size, sterility testing, Bacterial endotoxin test (BET), deviation control etc.

4. Knowledge of aseptic processing, microbiological analysis, cleaning room validation and monitoring.

5. Validation and Qualification: manage and review qualification of aseptic processing facility and equipment including DQ, FAT, SAT, IQ, OQ, PQ and calibration. Arrange routine validation of equipments such as, Autoclave, Dry heat sterilizes, Laminar airflow benches, filing lines etc. Designed and executed process validation for aseptic vaccine manufacturing processes.

6. Training: able to provide training on Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) and Standard Operating Procedure (SOP).

7. Batch Review and Release: Batch manufacturing record review and release of finish product.

8. Product registration, preparation of product summery file.

9. Documentation and Data Control: Coordinate with various stake holders for preparation of Technology Transfer Dossier, Site Master File, MFR, BMR, SOPs, validation protocol, validation reports, preparation of annual product review (APR) and change control, Data analysis and trending.

10. Stability studies: execution of the stability program of intermediate products and finished product as per ICH guidelines with regular monitoring.

11. Market complaint: coordination of market complaint, recording, investigation, reporting corrective and preventive action.

12. Artwork review and approvals.

13. Coordinate with supplier/ manufacturers on day to day quality and manufacturing issues.

14. Perform FMEA, Root cause analysis and other process related investigation.

 
Salary:
Best in Industry
Industry:
Pharma, Biotechnology, Clinical Research
Functional Area:
Engineering Design, R&D
Role Category:
Quality Assurance&Quality Control-Compliance& Regulatory
Role:
Quality Assurance&Quality Control Manager
Keyskills:
Quality Assurance, Quality Control,contract manufacturing
Desired Candidate Profile
Education:
(UG - Any Graduate - Any Specialization, Graduation Not Required) AND (PG - Any PG Course - Any Specialization, Post Graduation Not Required, M.Sc)
5-7 year of working in reputed pharmaceutical company.

Experiences in handling contract manufacturing organizations.

Experience in GMP/Quality System auditing.

(All required)

 
Company Profile
Elixir Web Solutions Pvt. Ltd
http://www.e-lixirweb.com
A leading US Healthcare Organization
Contact Details
Executive Name:
Nidhi Dosaj
Address:
Plot No. IT-25, Sahastradhara Road, Dehradun IT Park DEHRADUN,Uttaranchal,India 248001
Email Address:
Telephone:
08979006777
If above Post not related to you please forward to your friends..because its CAREER Matter. Refer www.pharmanaukri.info

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Enter your email address: Updated Regularly || Click here for Get Free SMS Alerts |

nmr

 Jobs By Category

Manufacturing/Production     Quality Control    Quality Assurance

Regulatory Affairs     Research & Development     Clinical Research

Warehouse/Stores HR Jobs     Contract Manufacturing     Supply Chain / PPIC

Purchase jobs      Marketing PharmacoVigilance 

 Jobs By Location

Baddi     Bhopal     Chandigarh     Solapur     Hosur     Gangtok     Gurgaon    

Mohali     Baroda Ankleshwar     Ahmedabad     Delhi      Mumbai      Chennai    

Hyderabad     Bangalore     Goa     Gujarat      Pune    

 Jobs By Qualification  

Ph.D     M.Sc     MBBS     M.Pharmacy     MBA     M.Com      M.Tech     B.Tech     

B.Pharmacy      B.Sc     D.Pharmacy     B.Com     Intermediate   Any Graduate      

ITI     SSC    

Jobs for Freshers

Freshers

Enter Key word then search

Share

Twitter Delicious Facebook Digg Stumbleupon Favorites