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.

Advantages:
Health insurance
Life insurance
Paid sick time
Provident Fund

Work Location: In person

📌 Quality Assurance Head Panchkula
🏢 Damaira Pharmaceuticals
📍 Panchkula