Pfizer Asst. Manager Quality Operations in Mumbai, India

Job Title: Assistant Manager, Quality Operations

Reports to: Team Leader, Quality Operations

Job Purpose:

  • 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. 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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.