Asst. Manager Quality Operations for Pharma Candidates @ Pfizer

Pfizer

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people.  Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Job Title:    Asst. Manager Quality Operations

Job Description:

• Contract manufacturing Quality Oversight activities and perform routine site visits for assigned CM sites as per Pfizer requirements.
• Work as team and support process validation activities at Contract Manufacturing Sites.
• Conduct assigned internal audits as per schedule / priority given.
• Responsible for review of batch records and QC data of contract manufacturing sites during visit and as and when required. Review of master BMR for assigned CM sites.
• Review and close monitoring of Deviations / OOS/ Change Controls, Stability Programme.
• Ensures implementation and adherence to GMP, GLP and Pfizer Quality standards.
• Support to departmental urgencies and Team leader for other assigned QA activities.

Position Responsibilities:

• Technical and Validation support to contract manufacturing sites
• Close co-ordination with contract manufacturing sites for monitoring product quality.
• Perform internal audits of Contract manufacturing Sites. Evaluate, recommend and implement necessary improvements in the system.
• Accompany Pfizer Global auditors during the assigned 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 perform Annual Product Reviews for the assigned products manufactured at CM sites.
• Documentation activities- revision of specifications, preparation of validation protocols, revision of SOP’s, etc.
• Perform assessment as per compendia changes and amend /distribute the updated documents to Contract manufacturing sites. Review and distribution of master documents at CM locations.
• Support in review of artworks, proofs and distribution it to CM locations.
• Use of computerized systems for quality system documents, ERP, complaint handling etc.

Qualifications: 

Skills / Knowledge / Qualification / Experience:

• Bachelor of Pharmacy / Master of Science
• Min 7-8 years of experience in QC and QA function
• Knowledge and hands on experience of QC testing
• Organized disciplined working, team working, self-learner and initiative in working
• Job requires travelling and flexibility in travelling

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