Deputy Manager- Quality Assurance- PR&D

Sai Life

0 years

6 - 9 Lacs

hyderābād

Posted:1 month ago| Platform: GlassDoor logo

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Skills Required

compliance training qc data sequence audit stability maintenance calibration verification reports

Work Mode

On-site

Job Type

Part Time

Job Description

Ensuring the 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 comphrensive assement 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.

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