QC - QMS & Compliance

• Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnel's and evaluation of effectiveness.
• Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines.
• Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance's.
• Responsible for review and approval of documentation such as SOP's, Specifications, STP's, TDS, reports for IRS, analyst qualification, etc.
• Responsible for Review and Approval of protocols, Qualifications and reports.
• Responsible for investigations and approval of OOS, OOT and deviations. To recommend and approve CAPA, change controls.
• Responsible for review and approval calibration and validation documents of instruments and equipment's.
• Responsible for review the analytical data and reports of samples handled in quality control laboratory.
• To release or reject the samples handled in quality control laboratory.
• Ensure compliance and adherence to data integrity.
• Responsible for review and approval of stability protocols, stability study summary reports, stability trends, stability calendar, stability analysis reports and stability matrix.
• Responsible for the review and approval of new software implementation and related documentation.
• Responsible for the review and approval of calibration matrix and planner.
• Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and laboratory incidents).
• Responsible for the preparation and review of audit responses (Internal and External).
• Responsible for monitoring of batch planning and execution to meet the batch release and stability release on-time or as per requirement.
• Responsible for reviewing of logbooks.
• Responsible for general place cleanliness and adherence of SOP / documents as per defined system.
• Responsible for work assigned by immediate supervisor.
• Responsible for the works carried out in absence of the designee.

Education: MSc, M Pharma, or Post Graduation in related field