Quality Control Stability Team Lead

Job Description:

• Managing all activities of the Stability department, including sample charging & pull-out plan,
• Sample allotment to analyst for analysis, analyst fallow up during analysis, trouble Shooting
• during analysis, maintenance & calibration of laboratory instruments and stability testing to
• ensure compendia, company, and regulatory compliance.
• ▪ Responsible for daily planning, products testing of QC stability.
• ▪ Execute commercial batches stability samples handling for receipt, charging chambers, timely
• pull-out.
• ▪ Support generation of all protocols for stability studies products.
• ▪ Assist in the generation of SOPs and Guidelines
• ▪ Manage laboratory equipment within the Stability department, including troubleshooting, repair,
• calibration, and qualification.
• ▪ Perform QC Stability review of GLP study final reports and other high visibility final reports to
• assure that calculations, content, reference are technically correct and complete for submission
• for QA Internal audits and External audits.
• ▪ Interpreting data and proper documentation for the observation with immediate reporting for
• OOS.
• ▪ Maintain the highest standard of safety, health, environment, cGMP and GLP in laboratory.
• ▪ Preparation of the Investigation Summary Reports for the OOT, OOS, and Deviations.
• ▪ Handling & Reviewing of QMS related documents such as Change Control, Deviations, and
• Internal Audit, CAPA etc.
• Conducting audits to ensure that all the products comply with the regulatory requirements w.r.t
• cGMP as per ICH, EU (GMP) EudraLex -Volume 4 Guidelines, ISO9001 and 21 CFR part 210 &211
• ,Quality System Regulations.
• ▪ Routine follows up Stability Chambers, Condition, in-travels, mapping, and samples.
• ▪ Routine checkup for Column management (New Column allotment, Usage, Storage) and
• ▪ accountability.
• ▪ Monitor routine maintenance and Calibration of equipment’s like HPLC, GC, UV, IR, and
• Dissolution.
• ▪ Review of Laboratory data integrity and Periodic checks of HPLC for Audit trials.
• ▪ Review of Laboratory instrument log & its maintenance log, equipment qualification reports etc.
• ▪ Sample Destruction of all samples as per Destructive procedures.
• ▪ Controlling of Hazardous and Poisonous Materials.
• ▪ Develop and maintained quality procedure documentation Used coordination and planning skills to
• achieve results according to schedule.
• ▪ Develop team communications and information for meetings.
• ▪ Independently applies scientific knowledge (both theoretical and practical) for the resolution of
• analytical chemistry problems.
• ▪ Be accountable for GMP compliance and safe working practices within the Analytical
• Development Laboratory.