HomeEngineeringAsst Manager/Dy Manager - Engineering | Pfizer India Ltd | Chennai

Asst Manager/Dy Manager – Engineering | Pfizer India Ltd | Chennai

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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.

Position: Maintainance Incharge

Location: Chennai, Tamil Nadu, India

Job Description:

Role Summary:

  • Responsible to perform Installation of equipment and validation activities of all Pharmaceutical laboratory equipment.
  • Responsible to perform Data integrity and Electronic records and Electronic Signature Assessment
  • Responsible to perform System audit trail periodic review
  • Must have experience in equipment/instrument qualification 8-11 years in the pharmaceuticals industry

Key Roles & Responsibilities

  • To be authored, reviewed CSV deliverables Validation Project Plan, IQ, OQ, PQ, Vendor Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report.
  • To Co-ordinate with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems, system suitability tests, and resolving technical issues
  • To be Responsible for designing calibration, and preventive maintenance schedules and ensure the timely completion of the activities.
  • To be Responsible for reducing the breakdowns and operating costs by implementing the effective preventive maintenance and support the analytical and clinical team to face all regulatory audits successfully

  • To be Responsible for maintaining Equipment related documentation for Audit purpose
  • To be Perform periodic Audit trail review and user management review for computerized and Non-computerized systems.
  • Through Knowledge of Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP) as per Pharma requirement.
  • Knowledge of Handling of Deviations/ Incident Change controls and Investigations etc in the Trackwise system.
  • Should possess In-depth knowledge in 21CFR part 11 compliance and requirement
  • Should have the ability to lead small teams.
  • Must have good negotiation and convincing skills

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