The Manager - Quality Assurance will be responsible for leading and managing Quality Assurance activities across pharmaceutical manufacturing and related operations, ensuring that all processes, products and documentation comply with established GMP standards, regulatory requirements, quality policies and company procedures.

The role will play a critical part in maintaining and continuously improving the organization's Quality Management System (QMS) and ensuring consistent product quality, patient safety and regulatory compliance throughout the product lifecycle.

The incumbent will work closely with Production, Quality Control, R&D, Regulatory Affairs, Engineering, Warehouse, Supply Chain and Technology Transfer teams to ensure that quality requirements are effectively implemented at every stage of manufacturing and product development.

Roles & Responsibilities:

- Manage day-to-day Quality Assurance activities for pharmaceutical manufacturing operations.

- Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, ICH and applicable regulatory requirements.

- Implement, maintain and continuously improve the Quality Management System (QMS).

- Review and approve SOPs, batch manufacturing records, specifications, protocols, reports and other quality documents.

- Review and disposition manufacturing batches in accordance with approved procedures.

- Manage deviations, CAPA, change controls, OOS/OOT investigations and quality incidents.

- Conduct internal audits, vendor audits and support customer/regulatory audits.

- Prepare the organization for regulatory inspections and coordinate inspection responses.

- Ensure effective implementation of documentation and data-integrity practices.

- Monitor GMP compliance across Production, QC, Engineering, Warehouse and other relevant functions.

- Review and approve validation and qualification documents, including process, cleaning, equipment and analytical validation.

- Oversee product quality review / APR/PQR activities.

- Investigate customer complaints and coordinate root-cause analysis and corrective actions.

- Support new product development, technology transfer and commercialization from a quality perspective.

- Evaluate and approve changes related to processes, equipment, materials and suppliers.

- Develop and monitor quality metrics and identify opportunities for continuous improvement.

- Train employees on GMP, quality systems, documentation practices and regulatory expectations.

- Lead and mentor QA professionals and build a strong quality culture within the organization.

Education:

- B.Pharm / M.Pharm / MSc in Pharmaceutical Sciences or equivalent qualification.

- 8 - 14 years of experience in Quality Assurance within the pharmaceutical industry.

- Strong experience in pharmaceutical manufacturing and Quality Management Systems.

- Good knowledge of GMP, GLP, GDP, ICH and regulatory compliance.

- Experience handling regulatory inspections such as USFDA, MHRA, WHO, EU or other international agencies will be preferred.

- Strong understanding of deviations, CAPA, change control, OOS/OOT, audits and validation.

- Experience in data integrity and pharmaceutical documentation.

- Strong analytical, investigation and problem-solving skills.

- Good leadership, communication and stakeholder-management capabilities.

Key Competencies:

- Quality Management Systems

- GMP Compliance

- Regulatory Audits & Inspections

- Deviation & CAPA Management

- Change Control

Key Performance Indicators (KPIs):

- GMP compliance score

- Successful regulatory/customer audits

- CAPA closure effectiveness and timelines

- Deviation and investigation closure

- Batch release timelines