Home Production Senior Associate - Quality Assurance | Pfizer Ltd | Mumbai

Senior Associate – Quality Assurance | Pfizer Ltd | Mumbai

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Position: Senior Associate – Quality Operations (Assurance)

Location: Mumbai, Maharashtra, India

Job Description:

External Supply Quality is responsible for the Quality management of contract manufacturers, packagers, and supply partners globally. The position has responsibility for the effective Quality Assurance Management oversight of Pfizer partners and suppliers who manufacture and package Pharmaceutical products on behalf of PGS.

The position is accountable for providing quality assurance management of key contractors and suppliers for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with cGMPs, the registration file, and country-specific requirements.

Key Roles & Responsibilities:

  • Responsible for the effective Quality Assurance Management oversight of the assigned contractors and suppliers who manufacture drug products and supply material to Pfizer.
  • Provide effective CQL role and responsibilities in the cross-functional virtual site operating teams (VSOT) of assigned contractors/suppliers.
  • Lead the implementation and support of Quality Assurance/Quality Control systems for drug products, raw materials manufactured and supplied by the Contract partner/supplier.
  • Develop and negotiate quality agreements.
  • Drive the development, implementation, and continuous improvement of Quality Systems to support Pfizer’s internal and regulatory requirements.
  • Proactively support MQSA and regulatory inspections at vendors and ensure tracking of Corrective and Preventative Actions (CAPA).
  • Provide Quality guidance for significant deviations at contractor sites.
  • Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
  • Lead quality risk management activities and manage mitigation plans within partners and suppliers.
  • Interactions with many internal business and manufacturing organizations (e.g., ES,  GTS, CMO, Procurement, Regulatory Affairs)

Qualification / Experience

  • Min Bachelor or Master of Science, Pharmaceutical Sciences or related technical discipline
  • Min 8 years’ experience in a GXP setting.
  • At least 4 years of Product Quality Assurance experience in a GMP environment
  • Experience with external suppliers/contractors
  • Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
  • Command of English language and multi-lingual is beneficial.
  • Good verbal and written communication including presentation skills
  • Ability to prioritize work, to act and work independently and to report items as required to Team leader
  • Take initiative and be proactive
  • Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
  • Has a broad GMP and technical know-how to handle emerging issues

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