Responsibilities To ensure testing and release of raw material ,excipient, packing material, microbiological sample, bulk and finished product. To ensure stability program conducted as per protocol To support validation team for process validation samples analysis management To ensure qualification ,calibration and maintenance of all laboratories instruments To ensure OOS investigation and reporting in time Control on lab. Related SOPs/PQS/PMSP –Reviews as per schedule Control on Reference standards management require for QC Laboratories To ensure CAP/ATS compliance To ensure that the activities in the QC Lab are in compliance with regulatory requirements To ensure Compliance and inspection readiness Verify compliance to Good Laboratory practice and Schedule L1of D & C act To conduct initial assessment of change control raised in area of operation Ensure monthly L1 audit of EHS/Quality as per schedule to identify gaps & timely closure of actions. Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audit and WHO audits Tracking of staff leave and promote for plan absenteeism. Unplanned absenteeism cases to be handle as per standard procedures. One on one discussion with staff to maintain discipline and building their capabilities. Coaching/counseling of staff for adherence to standards related to safety, quality & delivery. Quarterly Performance discussion with staff and ensure recording of NMS performance in PDP card. Coordination & monitoring of dept consumables & inventory. Handling of electronic systems (e.g. Empower, MERP, VQD, VQMS, SLIMS etc.) Resource management of laboratory to have smooth work function department is done in time. Ensure procurement for item required for quality department is done in time Site SQCS contact; ensure adequate QC support in vendor approval process .Timely analysis of purchase samples. To complete the QMS training in time and ensure the compliance with QMS in your area of operation. To carry out the gap analysis as per the requirement. To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements Risk management for department, Control on risk Log, Preparation of STPs and tracking of risks. To ensure monthly EHS meeting are happening and issues are discussed and sorted. Encourage staff for proactively identification of unsafe condition & unsafe behavior. Report it through ZAP process. Responsible for control on Chemical reagents and special hazards including sensitizers, Sensitizing and Biological agents Build an culture of reporting safety incidents and its closure within timeline with appropriate CAPA. To provide and support of EHS activities in Quality control. To ensure prevention of first aid cases/accident in department. To promote safety culture in Quality control department. To participate in RCAs as per requirement Ensure compliance to GPS principles (LSW, Gemba,3Z etc) Drive improvement with an approach of Kaizen & CIF. To ensure continuous improvement in laboratory working and to impart working of QC staff Support the functional head to establish the activities assigned or identified “as and when basis. To provide authorization/approval of QC documents. Control on safekeeping of controlled substances in QC laboratory.   Qualification & Experience M.Sc /B.Pharm/ M.Pharm 12-15+ years experience in Pharmaceutical Plant, 10+ years in QC Acquaintance with respect to job requirements  

Responsibilities Shall lead team of :10 OQ personnel ensuring shift-based oversight of GMP/ GDP/ Quality activities at site. Contact point for any quality issues in manufacturing/ packing operations at site. Ensuring in-process checks, adequate gap analysis, impact & risk assessments as per the QMS requirement. Ensuring manufacturing & packing operations as per validated & approved processes and prompt escalation of issues. Ensuring all-time Inspection Readiness and GxP & Data Integrity compliance site. Ensuring timely QA support in activities like investigations, line clearances etc. Review/ approval of MFRs, BMRs, SOPs, Change Controls, Deviations /Incidents/ OOS results investigations, CAPAs etc. Ensuring review of batch documentation, test results and all other documentation associated with batch certification. Management of Deviations, CAPAs, CAPA effectiveness and their trending. Appropriate updating, escalations and discussions in the Site Quality Council. Ensuring compliance to all regulatory and QMS requirements. Participate actively in OE / Leadership edge activity to ensure better implementation of QMS across the site. Ensuring inspection readiness and timely completion of actions in VQMS. Time bound compliance to Level-3 and Level-4 audits through CAPA tracking. Ensuring Site Quality KPI tracking through Inspection Readiness Dashboard. Planning and rational deployment of manpower and resource management for Value Stream OQ operations. Ensuring training & development of reportee’s in job competency, knowledge upgrade, personality development etc. To liaise with stakeholders like QC laboratory, Engineering, Technical, Warehouse and Production for relevant matters.   Qualification & Experience M. Pharm/ MSc / B. Pharm At least 15 years of experience  Experience in Quality Assuarance, IPQA, QMS, Quality Oversight in Prharmaceutical industry. Experience in Production, Validation & QMS in Pharmaceutical industry