Job Description:

  • Preparation of Documents related to Technology Transfer, Batch, Protocols of Qualification, Scale-up/Registration, etc
  • Preparing and issue of site variations and Query response docs.
  • Maintaining a record of Licences- Test/Manufacturing, Punch change part procurements, MFC
  • To ensure proper transfer of Documents to Plant QA from R&D
  • To review and approve change control, deviations and implementation of changes to meet the compliance
  • To co-ordinate predefined frequencies calibration for IPQA instrument & Equipment
  • Impart training to F&D team members on various aspects of GMP/GLP guidelines and practices
  • To co-ordinate predefined frequencies calibration for IPQA instrument & analytical Equipment’s and its periodic Review
  • Preparation of SOPs/Department Manuals, Formulation department manual and its issuance and its archival
  • To review periodically lab not book for the experiment carried out in labs
  • Maintenance of IQ, OQ, and PQ, manuals of equipment/ instruments and update
  • innovator sample management
  • Review the audit findings observations recommendations given in the audit report for compliance

Qualification: Appropriately Qualified

Experience: 2-5 Years

Job Location: Panjim, Goa


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