Key Responsibilities:
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.
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.
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.