Lead - Quality Control And Quality Assurance

Fact Personnel; Navi Mumbai; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Fact Personnel in Navi Mumbai seeks a seasoned Head of QA/QC to lead the site quality functions, ensure GMP compliance and patient safety. This role drives quality strategy, regulatory readiness and collaboration with cross-functional teams.

The ideal candidate has 15+ years in pharma manufacturing, strong QA/QC expertise, and proven leadership in regulatory inspections and continuous improvement initiatives.

Qualifications

• 15+ years of experience in pharmaceutical manufacturing.
• Strong experience in both QA and QC functions.
• Experience with USFDA audits and regulatory inspections.
• Knowledge of GMP and Quality Management Systems.

Responsibilities

• Lead QA/QC functions at the site and ensure product quality.
• Drive regulatory inspections, audits, and compliance activities.
• Oversee CAPA, deviations, change controls, OOS/OOT, investigations and validation.
• Mentor QA/QC team and collaborate with Manufacturing, Engineering, R&D, and Regulatory Affairs.
• Drive continuous improvement and quality culture.
• Ensure USFDA readiness.

Skills

Quality assurance

Quality control

Team leadership

Regulatory compliance

USFDA audits

Education

M.Sc. / Ph.D. in Chemistry, Pharmaceutical Sciences

Job description

Role & responsibilities

• Lead and oversee Quality Assurance and Quality Control functions at the site.


• Ensure compliance with GMP, regulatory requirements, and quality standards.


• Drive site-wide Quality Management Systems, CAPA, deviations, change controls, OOS/OOT, investigations and validation.


• Lead and coordinate regulatory inspections, customer audits and compliance activities.


• Ensure continuous USFDA inspection readiness and effectively manage regulatory audits.


• Provide strategic quality leadership and ensure product quality and patient safety.


• Lead, mentor and develop the QA/QC team.


• Collaborate with Manufacturing, Engineering, R&D and Regulatory Affairs teams to resolve quality and compliance issues.


• Drive continuous improvement and strengthen the site's quality culture.

Preferred candidate profile

• 15+ years of relevant experience in pharmaceutical manufacturing.


• Strong and balanced exposure to both QA and QC functions.


• Candidates from API / Bulk Drugs / Pharma Manufacturing backgrounds are preferred.


• Strong experience in USFDA audits and regulatory inspections.


• Excellent knowledge of GMP and Quality Management Systems.


• Proven experience in team leadership and quality function management.


• M.Sc. / Ph.D. in Chemistry, Pharmaceutical Sciences or a relevant discipline.