Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, the Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines, and animal health products.

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Position: Manager – External Quality Assurance – PQM

Location: Platina, Mumbai, India

Job Description:

  • Manager EQA/PQM is responsible for ensuring that all products managed by External Quality Assurance are manufactured, packaged, tested, released for further processing, stored, and distributed in accordance with our company’s expectations and all applicable regulatory requirements.
  • The PQM is responsible for batch release for further processing or final release of all products manufactured at the External Entity site.
  • The PQM will support External Entity relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following:
    • Number of products manufactured
    • Number of sites supported,
    • Production volumes,
    • Number and complexity of markets,
    • Historical performance (production and compliance),
    • new product or market launches,
    • the historical relationship between our company and the External Entity, and
    • manufacturing process complexity.

  • Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.
  • Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Key Responsibilities:

Primary activities include, but are not limited to:

  • Evaluate and/or release products to downstream sites for further processing or perform final release with the assurance that the goods were produced in conformance to all applicable company policies/procedures and compliance with all governing regulations; review and approve changes to masterbatch records or laboratory methods/ specifications.
  • Provide Independent Quality oversight to Repacking sites/external manufacturing sites, Batch record review, support for CDTL testing and product complaint coordination
  • support on Quality oversight of distribution centers in India, participate in the Selection and Qualification of new business partners.

  • Manage routine and complex deviations, coordinate the investigation of customer complaints, and assist in the coordination of significant investigations, Fact Findings and product recall involving the external partners, repackaging sites, and distribution network as required.
  • Provide support for company audits and inspections by regulatory agencies at the external partners, repackaging sites, and distribution networks as required.
  • Support analytical and process change control requests.
  • Oversee Stability Program management, including review of stability reports and quarterly reports, Prepare Annual Product Review.
  • Product Quality Complaint (PQC) Coordination
  • Support for Quality Oversight of Central Warehouse, Regional Hubs, CFA’s (Carrying and Forwarding Agents) and Super Distributors (SD), etc.).
  • Address in-market Quality issues, such as temperature excursion during in-market distribution, Interaction with in-country and regional stakeholders as Quality representative in the market.
  • Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
  • Track and monitor operational and quality performance of the External Entity and work with the site to develop CAPA plans as required for continuous improvement.
  • Support routine process validation.
  • Preparation of Quality Metrics (e.g. deviations, inspection outcomes, PQCs, CAPAs)
  • Self-Inspection planning, execution, documentation, and communication
  • Monitoring of Periodic TLRA’s, supporting new pack out qualification
  • Prepare pre-PAI assessments; support document requests for regulatory filings and post-approval changes.
  • Regular site visits to build relationships and monitor efforts to improve the External Entity’s quality and reliability through ongoing oversight and formal communication programs and forums.

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