Manager- QA
1 week ago
Key Responsibilities:
- Ensuring compliance in Quality control laboratory w.r.t. SOP's and regulatory requirements.
- Imparting training to QC Associates on SOP's and current regulatory requirements based on the review observations.
- Review of Analytical data such as Finished, Intermediate, Raw material and Stability.
- Review of electronic data and sequence audit trail against hard copy to ensure the accuracy of the analytical data.
- Review of Stability Protocols, Stability schedules and Stability data sheets.
- Review of master list of instruments, equipment's and Qualification document.
- Review of Preventive maintenance schedules, Calibration schedules and Calibration data of all Analytical Instruments in Quality control laboratory.
- Review of Method transfer/Method verification/Method validation protocols and Reports including Raw Data.
- Review of Reference Standards/Working Standards, data including Certificate of Analysis.
- Preparation of quality comparison sheets for all dispatched material to ensure the analytical trend.
- Review of monthly comprehensive assessment reports, laboratory errors and invalidation.
- Review of Analyst Qualification raw data.
- Audit trial review of all the standalone instruments and Empower in Quality control department.
- Review of certificate of analysis.
Key Competencies (Technical, Functional & Behavioral)
- Excellent verbal and written communication
- Persuasiveness
- Inter-personal skills
- Adaptability
- Foresight
- Understanding of business processes.
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