Sr. Executive

Job Title: Sr. Executive

Location: Bavla - Plant

Department: QA

Reporting To: Head of QA

Employment Type: Full-Time

Key Responsibilities:

• Prepare and review

  Cleaning Validation Protocols and Reports

  , including product matrix and MACO (Maximum Allowable Carry Over) calculations.
• Develop and execute protocols and reports for

  Clean Equipment Hold Time

  and

  Dirty Equipment Hold Time

  .
• Prepare, review, and finalize

  Process Validation Protocols

  and summary reports, utilizing analytical results and batch documentation data.
• Prepare and review

  Product Hold Time Protocols and Reports

  to ensure product quality throughout storage.
• Conduct thorough review of manufacturing documentation, including

  Master Formula Records (MFR), Manufacturing Process Records (MPR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR)

  .
• Review and analyze the

  Annual Product Quality Review (APQR)

  to assess product performance and compliance.
• Prepare and review

  Standard Operating Procedures (SOPs)

  to ensure alignment with regulatory guidelines and internal standards.
• Review

  Stability Study Protocols and Reports

  to support product shelf-life determination.
• Oversee the preparation, review, and execution of

  Qualification and Validation

  activities for equipment, systems, and processes.
• Review and monitor the

  Training Plan

  to ensure effective implementation and documentation of employee training.
• Review and maintain

  Document Control Procedures

  to uphold quality and compliance standards.
• Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.