QC - QMS & Compliance

Company Name: Enzene Biosciences Designation: Deputy Manager Department: Quality Control - QMS & Compliance Job Responsibilities: 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

• Experience: 0+ years
• Seniority: Mid Level
• Education: Bachelor's degree required
• Languages: English