Sr. Executive

4 days ago

Ahmedabad Bavla, India Avantika Medex Full time ₹ 1,04,000 - ₹ 1,30,878 per year

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.

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