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Description

To ensure that the Products provided to the market are tested as per Customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA /ISO guidelines.


Key Responsibilities:

  • SAP key user
  • To participate in Internal/External audit activities
  • To ensure compliance as per applicable regulatory requirement.
  • Release/rejection of finished products, intermediates & raw material as per approval specification
  • Creation & release of Certificate of analysis.
  • Issuance and review of Batch production records.
  • QC analytical data review.
  • Handling sales return, recalls and compilation of APR data
  • To coordinate investigation of market complaints/deviation/OOS/OOT.
  • Log books management for various activities.
  • To ensure that sampling of all Finished products are done as per defined procedure and proper record is being kept compliance to cGMP practice.
  • To ensure good housekeeping in the working area as well as in surroundings.
  • To ensure compliance to all SHE guidelines and to ensure safe working.
  • Conducting monthly safety audit and ensuring the closures of observations.
  • Reporting of Near misses/Incidents.
  • Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work .
  • Clearance of safety work permits to ensure execution of activities in safe manner.
  • To release the Batches of Intermediates and Finish goods in SAP.

Requirements

  • Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
  • Knowledge of documentation related to quality and regulatory guidelines.
  • Minimum 9 years of experience in Pharmaceutical industry and extensive Quality Assurance experience in API manufacturing industry.

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