Senior Executive- QA

1 day ago

Pithampur, Madhya Pradesh, India Lupin Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Roles and Responsibilities

  • Review and approval of Master Documents such as Batch manufacturing record /Batch packaging record, Specification, Standard test procedure, Standard operating procedure, Qualification/ Validation protocols and reports.
  • Preparation and review of Site Master File.
  • Review and approval of Quality System document such as Deviation, Change Control, OOS, OOT and Annual product review.
  • Handling of Market Complaints, FAR, Recall and Market withdrawal of Drug Products.
  • Responsible for Vendor Qualification, Batch release & SAP related activity.
  • To conduct self-audits and participation, review and implementation of regulatory and other audit compliance observation.
  • To perform CGMP quality audits and compliance of Cross Functional Department, External Manufacturing Sites, Suppliers/Vendors, Contract Testing laboratories and service providers as applicable.
  • To conduct management review meetings, site quality council meetings etc. and compilation of data, presentations and minutes of meetings.
  • Management of Control sample room for retention samples.
  • Ensure retention of documents and records as per regulatory requirements.
  • Review and approval of executed BMR/ BPR.
  • In-process Quality Assurance during production activity and sampling at different stages of Processing /Packing as per the requirement.
  • Review and approval of Hold time study protocols and summary report.
  • Review and approval of stability grid.
  • Review and implementation of CQA SOP at site.
  • Preparation and review of quality assurance SOP.

Desired Candidate Profile

  • Graduate degree in Pharmacy.
  • Excellent interpersonal & communication skills.
  • Must have worked in USFDA approved facility.
  • Must have worked in MDI, DPI, Derma & Nasal formulation.

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