Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Manager, Quality Operations
Responsibilities:
Job Purpose:
- Contract manufacturing Quality Oversight activities and perform internal audits
- Qualification and Validation activities at Contract Manufacturing Sites
- Conduct assigned QA audits as per schedule / priority given
- Responsible for review of bacth records and QC data of contract manufacturing sites
- Close monitoring of Deviations / OOS./ Change Controls, Stability Programme
- Ensures implementation and adherence to GMP , GLP and Pfizer Quality stds
- Support to overall QA activities
POSITION RESPONSIBILITIES :
- Technical and Validation support to contract manufacturing sites
- Co-ordination with contract manufacturing sites for monitoring product quality
- Perform audits of Off-Site manufacturers and suppliers. Evaluate and recommend necessary improvements in the system.
- Accompany MSQA auditors during the CM site audit and ensure CAPA closure
- Responsible for adoption and compliance with ICH and local regulatory requirements.
- Evaluate and improve upon existing methods and testing techniques; evaluate the use of new analytical methods, improved GLP practices.
- To update documents for sustaining and enhancing quality standards.
- Review of Dossiers
- To perform Annual Product Reviews for the products manufactured at CM sites
Candidate Profile:
- Bachelor of Pharmacy / Master of Science
- Min 7 -10 years experience in QC and QA function
- Knowledge and hands on experience of QC testing
Additional Information
Experience: 7-10 Years
Job ID: 1021401
Functional Area: QA/QC
Location: Mumbai
Last Date: 24th Dec. 2015
Or TO APPLY CLICK HERE AND PUT JOB ID. AND SELECT REGION: ASIA PACIFIC; COUNTRY: INDIA;
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