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 robust quality culture and customer-focused mindset across the organization.

📌 Quality Assurance - Manager, (Mumbai)
🏢 Galentic Pharma
📍 Mumbai