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.