Head Qa Qc

Zuche Pharmaceuticals Pvt. Ltd.; Bhiwadi; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Zuche Pharmaceuticals Pvt. Ltd. is seeking an experienced Head QA/QC to lead QA/QC operations for pharmaceutical and medical device products.

The role ensures product quality, regulatory compliance, QMS, audits, and data integrity in line with cGMP, GLP, ISO 13485, EU MDR, and applicable guidelines. You will manage QC labs, calibration, batch release, deviations, CAPA, change control, and audits, while mentoring teams and coordinating with Regulatory Affairs, Production, and R&D to maintain high

Qualifications

• 12 to 15+ years of QA/QC experience in pharma or medical devices.
• Deep knowledge of cGMP, GLP, ISO 13485, EU MDR, ICH guidelines.
• Experience with regulatory audits, quality systems, and team leadership.
• Strong leadership, analytical, problem-solving and communication skills.

Responsibilities

• Lead QA/QC operations and ensure compliance with regulatory requirements.
• Manage the Quality Management System (QMS), SOPs, documentation control, and quality compliance.
• Oversee batch release, deviations, CAPA, OOS/OOT investigations, and change control.
• Manage QC laboratories, including chemical, instrumental, and microbiological testing.
• Ensure calibration, qualification, and maintenance of analytical instruments.
• Lead regulatory, customer, and third-party audits and ensure timely closure of audit observations.
• Oversee medical device Design & Development documentation (DHF, DMR, Technical Files).
• Coordinate with Regulatory Affairs, Production, and R&D to maintain product quality and compliance.
• Develop and implement quality policies, procedures, and continuous improvement initiatives.
• Lead, mentor, and develop QA/QC teams and conduct GMP, GLP, and data integrity training.

Skills

Leadership

Analytical skills

Problem-solving

Communication

Education

B. Pharm

M. Pharm

M.Sc. in Chemistry

M.Sc. in Microbiology

Job description

Job Summary

We are looking for an experienced and dynamic Head QA/QC to lead Quality Assurance and Quality Control operations for pharmaceutical and medical device products. The candidate will be responsible for ensuring product quality, regulatory compliance, quality management systems, and audit readiness in accordance with cGMP, GLP, ISO 13485, EU MDR, and applicable regulatory guidelines.

Role & responsibilities

• Lead overall QA/QC operations and ensure compliance with applicable regulatory requirements.
• Manage the Quality Management System (QMS), SOPs, documentation control, and quality compliance.
• Oversee batch release, deviations, CAPA, OOS/OOT investigations, and change control.
• Manage QC laboratories, including chemical, instrumental, and microbiological testing.
• Ensure calibration, qualification, and maintenance of analytical instruments.
• Lead regulatory, customer, and third-party audits and ensure timely closure of audit observations.
• Oversee medical device Design & Development documentation, including DHF, DMR, and Technical Files.
• Coordinate with Regulatory Affairs, Production, and R&D teams to maintain product quality and compliance.
• Develop and implement quality policies, procedures, and continuous improvement initiatives.
• Lead, mentor, and develop QA/QC teams and conduct GMP, GLP, and data integrity training.

Preferred candidate profile

• B. Pharm, M. Pharm, M.Sc. in Chemistry, Microbiology, or a relevant pharmaceutical/science discipline.
• 12 to 15+ years of relevant experience in QA/QC within the pharmaceutical or medical device industry.
• Strong knowledge of cGMP, GLP, ISO 13485, EU MDR, ICH guidelines, and regulatory requirements.
• Experience in handling regulatory audits, quality systems, documentation, and team management.
• Excellent leadership, analytical, problem-solving, and communication skills.