Looking For Quality Assurance Manager

Quality Oversight & Approval

Approve analytical results, reports, protocols, methods, specifications, and other quality-related documents.

Ensure the integrity, accuracy, and regulatory compliance of analytical and laboratory data.

Provide final quality approval for services and deliverables provided to clients.

2. Quality Management System (QMS)

Establish, maintain, and continuously improve the Quality Management System (QMS) in compliance with GMP, GLP, and applicable regulatory guidelines.

Ensure effective management of SOPs, deviations, CAPAs, change controls, OOS/OOT investigations, complaints, and risk management activities.

Ensure data integrity compliance in line with ALCOA+ principles across all systems and documentation.

3. Regulatory Compliance

Ensure compliance with applicable global regulations and guidelines, including FDA, EMA, ICH, WHO, and ISO standards.

Lead, support, and manage regulatory inspections, client audits, and third-party audits.

Act as the primary quality point of contact for regulatory authorities, auditors, and customers.

4. Systems & Validation

Review and approve validation activities including analytical method validation, equipment qualification (IQ/OQ/PQ), computer system validation (CSV), and process validation.

Ensure laboratory instruments, electronic systems, and software meet regulatory and data integrity requirements.

5. Training & Quality Culture

Ensure appropriate training of personnel on GMP, GLP, SOPs, and quality best practices.

Promote and sustain a strong quality culture and compliance mindset across the organization.

6. Risk Management & Continuous Improvement

Identify potential quality and compliance risks and implement effective mitigation strategies.

Drive continuous improvement initiatives to enhance regulatory compliance, operational efficiency, and service quality.

• Experience

  5 - 11 Years

• No. of Openings

  1

• Education

  Graduate (B.Pharma, B.Sc)

• Role

  Quality Assurance Manager

• Industry Type

  IT-Hardware & Networking / IT-Software / Software Services

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office