Dy. Manager/Assistant Manager Quality Assurance - Healthcare Division

Role & responsibilities

Document Control and Quality Management:

• Review, approve, and maintain Standard Operating Procedures (SOPs), Work Instructions, and other quality-related documents to ensure compliance with internal procedures and external regulatory requirements.
• Lead and coordinate change control processes, ensuring proper documentation and regulatory compliance during changes to processes, materials, and equipment.
• Review and approve Deviation Reports, OOS/OOT Reports, and related investigations to ensure all findings are accurately documented, addressed, and corrective actions implemented.

Compliance Monitoring:

• Ensure continuous compliance with applicable standards, including ISO 13485, ISO 15378, MDSAP, and other relevant regulatory requirements.
• Oversee the management of cleanroom compliance, ensuring adherence to GMP (Good Manufacturing Practices) and environmental monitoring protocols.
• Conduct regular internal audits to assess adherence to QMS standards, identify gaps, and implement corrective/preventive actions.

Management Representative (MR) Role:

• Act as the primary point of contact for the management review of quality management system activities.
• Coordinate and lead QMS-related activities for audits, CAPAs (Corrective and Preventive Actions), and internal and external assessments.
• Ensure effective communication between top management and operational teams on quality assurance matters, escalating issues and providing timely solutions.

Customer Interaction and Query Response:

• Act as a liaison between the company and customers for quality-related inquiries, complaints, and documentation requests.
• Review and provide timely and accurate responses to customer queries, ensuring proper root cause analysis and corrective actions are communicated.

Qualification and Validation:

• Review and approve Qualification Protocols and Reports (including IQ, OQ, PQ) for equipment, processes, and systems.
• Ensure that qualification and validation activities align with both regulatory requirements and company policies.

Training and Development:

• Provide guidance and support to junior team members and employees regarding QMS requirements, SOPs, and quality assurance processes.

Identify training needs and participate in the development and delivery of quality management and compliance-related training programs.

Preferred candidate profile

• In-depth knowledge of ISO 13485, ISO 15378, MDSAP, and other relevant regulations.
• Thorough understanding of quality management systems (QMS), Good Manufacturing Practices (GMP), and industry standards.
• Experience with cleanroom compliance, environmental monitoring, and GMP documentation.
• Familiarity with handling customer complaints, regulatory inspections, and audit processes.