Enzene Hiring QC Deputy Manager

Enzene is a technology driven company based in Pune, India. We strive to harness disruptive innovation to enhance global health. Our aim is to provide, affordable, quality medicine for aiding lives with debilitating conditions. Enzene has invested in world class R&D infrastructure which allow access to technologies of the future. Enzene has end to end development platform from our own propriety CHO duos cell lines, to high throughput upstream and downstream platforms, comprehensive drug product development capabilities backed by state of the art advanced analytical technologies supports speedy development of pre-clinical and clinical drug candidates.

Post : QC - QMS & Compliance

Designation : Deputy Manager

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.

Additional Information
Experience : 0 - 12 Years
Qualification : MSc, M Pharma, or Post Graduation in related field
Location : Pune, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QMS & Compliance
End Date : 30th October 2026