Quality Assurance - Manager,

Galentic Pharma; Navi Mumbai; On-site; INR 900,000 - 1,600,000; Full time

Job summary

Galentic Pharma is seeking an Assistant Manager - QA to lead and enhance quality assurance activities in sterile/semi-solid product manufacturing. The role oversees QA operations across manufacturing, QC, and support functions with emphasis on CAPA, deviations, change controls, and audits.

The ideal candidate will have extensive QA/QMS experience, strong regulatory knowledge, and proven leadership in building a quality culture and ensuring inspection readiness.

Qualifications

• Extensive QA/QMS experience in pharmaceutical sterile/semi-solid ointment manufacturing.
• Strong knowledge of cGMP, GLP, ICH guidelines, ISO 9001:2015 & ISO 13485:2016.
• Proven track record in leading end-to-end QA operations across multiple functions.
• Experience with CAPA, deviations, change controls, OOS/OOT/OOC, non-conformances, recalls and investigations.
• Exposure to regulatory inspections and audits (customer, vendor, third-party manufacturing).
• Audit readiness, audit responses, root-cause analysis and CAPA effectiveness.

Responsibilities

• Lead end-to-end QA operations across manufacturing, QC, warehouse, and engineering.
• Drive QMS, CAPA, deviations controls and ongoing improvements.
• Oversee batch release, stability programs, qualification, calibration and validation activities.
• Ensure data integrity and compliance with national/international regulations.
• Coordinate regulatory inspections and vendor/customer audits.
• Provide leadership in manpower planning, training and performance management.

Skills

Quality Assurance

QMS

CAPA

Deviations

Audits

Data integrity

Regulatory compliance

Leadership

Cross-functional coordination

Tools

SAP

DOCS IQ

Learn IQ

Caliber/eQMS

Job description

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.