Executive/SR.Executive(BTQA)

For Sr.Executive :

• Preparation of SOPs, Formats, Protocols, Reports, Qualification related documents.
• Review of BMR, MFR and TT related documents
• Handling of QMS documents (Change controls Deviations, and CAPAs).
• Execution of Commissioning and Qualification related activities by coordinating with cross functional teams
• Handling of cleaning validation related activities
  
• Handling of vendor qualification activities
• Handling of Batch release activity.
• Preparation o Review and approval of APQR Qualification related documents.
• Prepare and execute computerized system validation/qualification activities in accordance with approved procedures and validation plans.
• Develop and review validation documentation i.e. URS, FDS, risk assessments, IQ, OQ,
• PQ, RTM and Summary reports.
  
• For Executive:
• Document Issuance, retrieval and archival of documents for cross functional teams.
• Preparation, review of SOPs, formats, Protocols, Reports, Qualification related documents