Key Responsibilities

Lead the overall Quality Assurance function for the pharmaceutical formulation/OSD facility.

Establish, implement, and maintain robust Quality Management Systems (QMS) in compliance with applicable GMP and regulatory requirements.

Provide strategic and operational leadership to the QA team at the site.

Ensure compliance with US FDA, MHRA, TGA, ANVISA, EU GMP and other applicable regulatory requirements.

Lead preparation, coordination, and management of regulatory inspections and customer audits.

Ensure timely investigation, response, CAPA implementation, and closure of audit/inspection observations.

Oversee deviations, OOS/OOT, CAPA, change controls, complaints, product quality reviews, risk assessments, and investigations.

Ensure effective implementation and continuous improvement of the site's QMS.

Review and approve quality-related documents, procedures, protocols, reports, specifications, validation documents, and other controlled documents as applicable.

Provide QA oversight for manufacturing, packaging, validation, technology transfer, qualification, and other GMP activities.

Ensure appropriate batch release and compliance with approved specifications and regulatory requirements.

Drive quality culture and GMP awareness across the organization. Maintaining continuous inspection readiness and tracking changes in applicable regulations/guidelines

Designation





Head Site QA - AGM / DGM

Department

Quality Assurance

Qualification

M. Pharm

Specialisation

Quality Assurance – Formulations / Oral Solid Dosage (OSD)

Experience (yrs)

20+ years of relevant experience in Pharmaceutical Quality Assurance

Location

Bangalore

Interface with Regulatory Affairs, R&D;, Manufacturing, QC, Engineering, Supply Chain, and senior management on quality and compliance matters.

Lead and mentor the QA team, including succession planning and capability development.

Identify quality risks and drive continuous improvement and compliance excellence across the site.

Responsible for data integrity across QA, QC, manufacturing and computerized systems. Experience with ALCOA+ principles and electronic records/audit trails

Skills and Competencies The candidate must have handled in at least 3 regulatory audits from USFDA/MHRA/EDQM/TGA/ANIVISA within the last 3 years. At least 1 audit must have been conducted within the last 1 year.

Quality Assurance & QMS leadership

US FDA / MHRA / EU GMP / TGA / ANVISA compliance

Deviation, OOS/OOT, CAPA and change-control management

Risk management

Root-cause analysis and problem solving

Quality metrics, management review and continuous improvement

Team leadership and people development

Excellent communication and documentation skills

📌 Head Site QA /AGM / DGM (Bengaluru)
🏢 Bioplus Life Sciences
📍 Bengaluru