Quality Assurance Head

• 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.

Benefits

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

Work Location: In person