- Lead and manage the Quality Assurance department, including QA operations, QA systems, validation, qualification, and documentation.
- Ensure compliance with cGMP, GDP, GLP, and applicable regulatory requirements.
- Maintain and continuously improve the Pharmaceutical Quality System (PQS).
- Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), protocols, reports, specifications, and quality-related documents.
- Review and approve investigations related to deviations, Out of Specification (OOS), Out of Trend (OOT), change controls, CAPA, and risk assessments.
- Oversee qualification and validation activities, including equipment, utilities, cleaning, process validation, and computerized systems where applicable.
- Ensure timely review and approval of batch records and disposition of finished products.
- Lead internal audits,



supplier audits, and regulatory inspections.
- Coordinate responses to regulatory observations and ensure timely implementation of CAPAs.
- Ensure compliance with data integrity requirements (e.g., ALCOA+ principles).
- Monitor quality metrics and drive continuous improvement initiatives.
- Provide quality oversight for manufacturing, quality control, warehousing, engineering, and distribution.
- Develop and mentor QA personnel through training and performance management.
- Participate in management review meetings and provide strategic quality direction.

Perks:

- Health insurance
- Life insurance
- Paid sick time
- Provident Fund

Work Location: In person

📌 Quality Assurance Head (India)
🏢 Damaira Pharmaceuticals
📍 India