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Asst/Dy Manager

7.00 to 8.00 Years   Chennai   25 May, 2020
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Qualifications:B.E(Instrumentation)/ B.tech(Instrumentation) with 7 to 8 Years of Experience in relevant industry.Role:

  • Responsible to perform Installation of equipment and validation activities of all Pharmaceutical laboratory equipment s.
  • 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 7-8 years in pharmaceuticals industry
Job description:
  • 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 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 on Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP) as per Pharma requirement.
  • Knowledge on Handling of Deviations/ Incident Change controls and Investigations etc in Trackwise system.
  • Should possess In depth knowledge in 21CFR part 11 compliance and requirement
  • Should have ability to lead small team.
  • Must have good negotiation and convincing skills
#LI-PFEPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Engineering,

Keyskills :
equalemploymentopportunity continuousimprovementfacilitation audittrail systemaudit vendoraudit auditreport dataintegrity riskassessment usermanagement tatementsofworksow

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