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.

- Robust 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.

2) 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.

1. 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.

📌 Quality Assurance - Manager , IPQA Officer & QMS Officer (Mumbai)
🏢 Galentic Pharma
📍 Mumbai