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Job Overview

  • Date Posted
  • Location (State / UT)
  • Expiration date
  • Experience
    15 Years, 20 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree
  • Salary in (₹)

Job Description

  • To ensure cGMP Compliance in the plant.
  • To review and approve all departments’ Standard Operating Procedure.
  • To ensure compliance with all Standard Operating Procedures.
  • \Strategic Planning & execution of Quality Management System.
  • \To ensure the compliance of the Quality Management system as per the requirement.
  • Responsible for leading the external audit & providing compliance in a timely manner.
  • \To review and approve the Site Manager File (SMF), Validation Master Plan(VMP), and Quality manual.
  • Responsible for the approval and release of the Batch.
  • To review & approve specifications, Standard Test Procedure (STP), and General Test Procedure (GTP) of the Quality Control Department.
  • Responsible for Self Inspection or Internal Audit and its compliance.
  • To review and approve all Validation and Qualification Protocols and Reports.
  • To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
  • Perform laundry audits in coordination with the HR department.
  • To impart training on different topics including cGMP and GDP etc.
  • To coordinate during technology transfer of products to the sites.
  • To ensure that products are manufactured as per the approved procedure.
  • Responsible for the investigation of the market complaints, Product recall & compliances.
  • Responsible for review, approval, and implementation, and verification of Corrective Action and Preventive Action.
  • To provide compliance reports of audits.
  • To give the final approval for Art Works.
  • To conduct interviews and recruitments of Quality Assurance Personnel.
  • To ensure the Qualification and Re-qualification of the Equipment, Facility, and System
  • Responsible for review and approval of Stability Protocol and report.
  • To ensure work discipline in the department.
  • Responsible for quality agreement and its compliance.
  • To review and approve all apex documents.

Qualification: B.Pharma, M.Pharma, MS/M.Sc