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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.

Best in Industry
Pharma, Biotechnology, Clinical Research
Functional Area:
Engineering Design, R&D
Role Category:
Quality Assurance&Quality Control-Compliance& Regulatory
Quality Assurance&Quality Control Manager
Quality Assurance, Quality Control,contract manufacturing
Desired Candidate Profile
(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
A leading US Healthcare Organization
Contact Details
Executive Name:
Nidhi Dosaj
Plot No. IT-25, Sahastradhara Road, Dehradun IT Park DEHRADUN,Uttaranchal,India 248001
Email Address:
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