Section Head- Quality Assurance - QA In QC Division

Experience: 20 to 25 years

Location: Moraiya, India

Skills: cGMP, GLP, Data integrity, CAPA, QMS, Trackwise, documentum, ZyTims, MES, SAP, Laboratory compliance, GDP, Quality risk management

Job Responsibilities:
cGMP Compliance:
1. To ensure 24X7 compliance, all time audit readiness of QC labs.
2. To lead and manage the strategic and operational performance of the QA in QC department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success.
3. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.
4. To ensure the quality systems are maintained in compliance with corporate standards.
5. To work on continuous cGMP/GLP enhancement, improvements in method and analysis with software control related to laboratory practices.
6. To ensure implementation of global CAPA’s at all QC labs.
7. To review, assess and appraise significant product quality and product safety issues to senior management and track the execution.
8. To provide regulatory support on issues to submission/review response related to deficiencies related to analytical testing.
9. To ensure implementation of quality risk management for proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality.
10. To review and approve OOS, OOT, deviations, change control and associated impact assessment.
11. To review the Laboratory QMS tracker and ensure that all QMS documents are meet the requirement and are up to the mark.
12. Responsible for the review and approval of laboratory QMS documents in software like, Trackwise, documentum, ZyTims, MES and SAP/ERP wherever applicable and its implementation.
13.



To ensure cGMP related trainings to personnel at all QC labs.
Laboratory compliance:
QC Data Review/Release/Controlled laboratory practice/ Laboratory Investigation
1. To review and approve analytical specifications, standard and general test procedures, test data sheet, and inspection plan for raw material, packing material, intermediate, drug substance, semi -finished, finished product, stability and microbiology.
2. Responsible for quality oversight of personnel, process and practice to meet the compliance requirement, contemporaneous documentation and documentation control.
3. To review & verify electronic data/ audit trail before laboratory disposition of the batch.
4. Responsible for QC release of RM/ PM/ In-process /FP.
5. To review of stability protocols in coordination with stability group and review the stability report.
6. To ensure retrieval of QC data and support for its presentation during audit.
7. To ensure controlled laboratory practice and GDP in area/instrument up keeping.
8. To perform random checks in personal computers with respect to desktop policy and to ensure housekeeping of system and area.
9. To participate in investigation of OOS, OOT, deviation/incidences, non-conformances. Keep track of investigation progress and presentation of topic. Conduct periodic review, CTF discussion to timely closure of open non conformances.
Audit and Compliance:
1. To conduct the GEMBA round at all QC labs and to ensure inspection readiness at site.
2. To ensure periodic internal audits performed as per approved yearly audit schedule.
3. To review and approve compliance report following the external (customer/regulatory) audit and corporate audit and ensure compliance as per the report.
4. Responsible to fulfil the compliance to audit commitments completion rate.
5. To coordinate with other CFT team members like Production, HR, engineering, QC, warehouse for compliance as per cGMP and regulatory requirements and corporate quality policy.

📌 Section Head Quality Assurance QA In QC Division (Mumbai)
🏢 Zydus Lifesciences
📍 Mumbai