Head - Quality Control- L3-L4

Company Overview:

Role Summary:

Key Responsibilities:

• Lead and manage the QC department including chemical, instrumental, and microbiology labs.
• Ensure compliance with cGMP, GLP, ICH, and other regulatory requirements.
• Review and approve specifications, test procedures, and analytical reports.
• Oversee sampling and testing of raw materials, packaging materials, in-process and finished products.
• Ensure timely release of materials and products with strict adherence to quality standards.
• Coordinate stability studies and method validation activities.
• Handle deviations, out-of-specification (OOS) results, investigations, and implement CAPAs.
• Interface with regulatory authorities and support audits/inspections (e.g., WHO-GMP, EU, USFDA, etc.).
• Ensure continuous training and development of QC personnel.
• Maintain and review QC documentation, including SOPs, protocols, reports, and logbooks.
• Collaborate with QA, Production, RA, and other departments for smooth quality operations.

Qualifications & Experience:

• M.Sc. / B.Pharm / M.Pharm in Chemistry, Pharmaceutical Sciences, or related field.
• 12–18 years of experience in Quality Control in the pharmaceutical industry.
• Minimum 3–5 years in a leadership role in QC.
• Strong knowledge of analytical instruments (HPLC, GC, UV, IR, etc.).
• Hands-on experience with regulatory audits and compliance requirements.
• Excellent analytical, leadership, and communication skills.

Preferred Candidate Profile:

• Experience in formulations (oral solids/Nasal) is desirable.
• Exposure to international regulatory standards (e.g., USFDA, EU, TGA) is an added advantage.
• Ability to drive quality culture and implement continuous improvement initiatives.