Site Name: Pakistan – Sindh – Karachi
Posted Date: Sep 21 2020
Job Purpose To ensure that Lab operations documentation such as self-inspection CAPA management Deviation management at departmental level, Risk management at departmental level, Test method updating, Specification review, etcMinimum Level of EducationM.S c Chemistry or Pharm-D or equivalentArea of SpecialisationOrganic/Analytical/Inorganic Chemistry, Applied Chemistry, Microbiology or Pharmacy or equivalentMust have an experience of approx 3 years on the same (or equivalent) position.Key Responsibilities
- Management of reference standards.
- Management of Quality Management system in Lab operations non-penicillin to ensure the In-place In-use of all SOPs related to Lab operations.
- To ensure the pharmacopeal compliance of test methods.
- To manage Management Monitoring Level 1 Audit of Lab Operation (NP) on monthly basis.
- To manage weekly/monthly reports to Operation Quality.
- To manage LE data to operational quality.
- To identify the FIT ‘fast improvement tracks.
- To ensure that Documentation of Change control, Deviation related to Lab Operation (NP) are properly managed in effective & efficient manner to close the change control and deviation timely.
- To register All CAPAs of L1 & L2 Audit Findings in QWF for tracking and Closing Purpose.
- Review & revision of Internal factory specifications and test methods.
- To ensure that L1, L2, L3 audits CAPAs generated and tracked in QWF in a well define manner to avoid any missing/overdue.
- Review & Approval of Liquid/Raw materials/Tablets/ Utility Documents as & when required.
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