Head Site QA /AGM / DGM

Bioplus Life Sciences Pvt. Ltd.; Bengaluru; Sur place; INR 4 000 000 - 7 000 000; Plein temps

Résumé du poste

Bioplus Life Sciences Pvt. Ltd. in Bengaluru seeks a seasoned Head Site QA (AGM/DGM) to lead the Quality Assurance function for the pharmaceutical formulation/OSD facility. You will establish and maintain QMS, ensure regulatory compliance with US FDA, MHRA, TGA, EU GMP, ANVISA, and manage inspections.

The role requires 20+ years in QA, an M. Pharm, and proven leadership to drive continuous improvement, data integrity, and quality culture across QA, QC, manufacturing and technology transfer.

Qualifications

• 20+ years of relevant experience in Pharmaceutical Quality Assurance.
• M. Pharm degree.
• Proven experience in US FDA / MHRA / EU GMP / TGA / ANVISA regulatory compliance.
• Experience leading QA team and site audits.

Responsabilités

• Lead the overall QA function for the pharmaceutical formulation/OSD facility.
• Establish, implement, and maintain robust QMS in compliance with GMP/regulatory requirements.
• Provide strategic and operational leadership to the QA team at the site.
• Coordinate regulatory inspections and customer audits and ensure timely CAPA closure.
• Oversee deviations, OOS/OOT, change controls, complaints and ongoing product quality reviews.
• Drive continuous improvement and data integrity across QA, QC, and manufacturing.

Connaissances

QA leadership

Regulatory compliance

CAPA management

Risk management

Data integrity

Documentation skills

Team development

Communication

Formation

M. Pharm

Description du poste

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