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Friday, 5 July 2013

Executive, Quality Operations-India-Thane-Pfizer

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PfizerJobs
Executive, Quality  Operations
983401
India-Thane
07/24/2013
Full-TimeRegular
 
Role Description
Responsibilities

• Support the Quality Control and Quality Assurance Function 
• Support the Quality Operations team for the activities related to testing, specifications and manufacturing according to the principles of cGMP / GLP and in line with the corporate policies and guidelines.

Job Description:

- Preparation / Review of Annual Product Review
- Preparation / Review of BMR’s /BPR / SOP’s
- Close monitoring of Deviations, Change Controls and OOS
- Support Manager, QA for overall QO function 
- Support Technology Transfer, AMTE, Method and Process Validations
- Review and approval of artworks
- Documentation for all these activities
- Co-ordination and compilation of Stability results, Calibration records of  QC instruments
- Technical / Analytical support to Quality Control for in-house testing as well as off-site testing.

Job Specification

1. Qualification

- Graduate in Pharmacy or Master in Science
- Minimum 5 -7 years experience in Pharmaceutical Industry (QC / QA function).
- FDA Approval

2. Special Skills & Knowledge

- Knowledge of GMP and Quality Systems.
- Knowledge of Drugs and Cosmetics Act , ICH  guidelines.
- Knowledge of GLP, Quality control analysis

3. Key Competencies

- Interact with peers and superiors on regular basis
- Flexibility
- Good Documentation Skills
- Training
- Analytical Thinking
- Interpersonal Sensitivity

ALL INTERNAL CANDIDATES MUST HAVE THE APPROVAL OF THEIR MANAGER PRIOR TO APPLICATION.
 
 
Additional Offer Details:
Previous Item
Foreign nationals whose eligibility to work requires sponsorship or maintenance of valid immigration status may not be eligible for this position.
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Relocation Package Available

Management retains right to change the job specifications and provisions of this job as appropriate.

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