Quality Assurance - Asst.Manager / IPQA Officer/QMS Officer

1) Job Profile - Assistant Manager -QA:

Key Profile Highlights

• 1218+ years of experience in Quality Assurance/QMS within pharmaceutical Sterile / Semi Solid Ointment formulation regulated manufacturing industries.
• Strong expertise in cGMP, GLP, ICH guidelines, ISO 9001:2015 & ISO 13485:2016.
• Proven experience in leading end-to-end QA operations across manufacturing, QC, warehouse, engineering, and other functions.
• Expertise in QMS, CAPA, deviations, change controls, OOS/OOT/OOC, non-conformances, complaints, recalls, and investigations.
• Strong exposure to regulatory inspections, customer audits, vendor audits, and third-party manufacturing audits.
• Hands-on experience in inspection readiness, audit responses, root-cause analysis, and CAPA effectiveness.
• Expertise in batch release, product rejection, process validation, APQR, stability programs, qualification, calibration, and validation activities.
• Strong understanding of data integrity and national/international regulatory requirements.
• Experience as Management Representative for ISO implementation and QMS compliance.
• Proven ability to lead Quality teams, manpower planning, training, recruitment, budgeting, and performance management.
• Experience in quality metrics, Management Review, continuous improvement, and quality initiatives.
• Working knowledge of SAP, DOCS IQ, Learn IQ, and Caliber/eQMS platforms will be an added advantage.
• Strong leadership, stakeholder management, communication, analytical, and decision-making skills.
• Ability to drive a strong quality culture and customer-focused mindset across the organization.

Job Profile - IPQA OFFICER :

• Perform line clearance for sterile and non-sterile manufacturing, filling, and packing.
• Conduct in-process quality checks and review BMR, BFR, and BPR.
• Verify dispensing, packaging materials, cartons, and labels.
• Monitor aseptic practices and ensure cGMP compliance on the shop floor.
• Perform bulk, finished product, rinse, and swab sampling for validation.
• Manage sample requisitions, retention samples, and material release in SAP/LIMS.
• Support internal, customer, and regulatory audits while maintaining documentation in DOCS IQ, Learn IQ, and EPIQ.

Job profile for QMS Officer :

• Implement, maintain and troubleshoot Assure IQ software and manage CAPA for timely closure.
• Coordinate Learn IQ training, including training needs matrix and annual/monthly training calendar.
• Conduct ISO Management Review, MQRM and Self-Inspection activities.
• Review specifications, stability protocols/reports, artworks, shade cards and batch documents (MFR/BMR/BFR/BPR).
• Ensure compliance with ISO 9001:2015, ISO 13485:2016 and site quality systems.
• Manage document issuance, revision, retrieval and archival through DOCS IQ.
• Maintain and review site licences, Site Master File and Quality Manual.
• Review QC/Microbiology logbooks and release water analytical reports through LIMS.
• Participate in internal/customer audits and regulatory inspections.