Senior Quality Assurance Officer

The Senior Quality Assurance Officer will be a critical member of the QA team at our Paonta Sahib manufacturing facility. Reporting to the Head of Quality Assurance, you will be responsible for ensuring all pharmaceutical manufacturing activities comply with WHO-GMP, ICH guidelines, and Indian Schedule M requirements across solid oral dosage and liquid dosage form production lines.

You will work closely with manufacturing, regulatory affairs, and warehouse teams to maintain robust quality systems, lead root cause investigations, and drive continuous improvement initiatives that directly impact patient safety and product efficacy.

This is a high-ownership role within an organisation that holds quality as a core value. You will have the opportunity to shape QA practices at one of India’s leading pharmaceutical manufacturers, with direct exposure to global regulatory inspections (WHO, MHRA, TGA, ANVISA).

• Review and approve batch manufacturing records (BMRs), batch packaging records (BPRs), and standard operating procedures (SOPs) for compliance with GMP requirements.
• Lead internal quality audits of manufacturing, packaging, and warehouse areas; prepare audit reports and track corrective and preventive actions (CAPAs) to closure.
• Investigate out-of-specification (OOS) results, customer complaints, and product deviations; conduct thorough root cause analysis and implement corrective actions.
• Oversee in-process quality checks during manufacturing operations and ensure compliance with approved specifications and procedures.
• Review and approve change control proposals, risk assessments, and validation protocols (process, cleaning, method, equipment).
• Participate in regulatory inspections (CDSCO, WHO, MHRA, TGA) as a functional expert; prepare facility and documentation for inspection readiness.
• Train manufacturing and QC staff on GMP principles, SOPs, and quality system requirements.
• Collaborate with regulatory affairs for dossier compilation, site master file updates, and product quality reviews (APQRs).
• Monitor quality metrics (OOS rate, CAPA closure rate, deviation trends) and present monthly quality KPI reports to management.

Essential

• B.Pharm or M.Pharm from a recognised institution; M.Pharm preferred.
• 5–7 years of QA experience in a WHO-GMP compliant pharmaceutical manufacturing facility.
• Deep knowledge of ICH Q7, Q9, Q10; Schedule M (revised); and relevant WHO/PIC/S guidance documents.
• Hands-on experience with batch record review, CAPA management, OOS investigations, and change control.
• Experience supporting at least one international regulatory inspection (WHO, MHRA, TGA, or equivalent).
• Proficiency with quality management systems (QMS) software; experience with SAP QM is an advantage.

Preferred

• Experience in solid oral dosage forms (tablets, capsules) and/or liquid dosage forms (syrups, suspensions).
• Six Sigma or Lean certification beneficial but not mandatory.
• Strong written and verbal communication in English; Hindi proficiency advantageous for site communication.
• Ability to work under pressure, manage multiple investigations simultaneously, and meet regulatory deadlines.