- Issue and authorize all controlled document within the organization.
- Performs supplier audits for all supplies.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and intrusted parties needs and expectations.
- Implements and maintains the GMP program and processes to ensure high quality products and compliance with current GMPs.
- Implements and maintains the Document Control system, training programs and processes to ensure high controlled management systems and compliance with cGMP guidelines and ISO requirements.
- Supervising the implementation of changes to controlled documents to ensure defined quality objectives are met.
- Leader for the Risk management team.
- Collaborates with Top Management to issue annual training plan.
- Collaborates with Top Management to issue annual objectives.
- Coordinate, perform and evaluates the effectiveness of trainings, implementing modifications when necessary, and monitors training compliance for staff.
- Maintains systems to ensure integrity and security of all documents containing data relevant to management systems.
- Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
- Manages the document periodic review process.
- Ensure the implementation of GMP concepts through all departments.
- Perform internal audits through all department to ensure the correct implementation of cGMP guidelines, IMS and interested parties needs.
- Manages the collection and maintenance of department metrics.
- Provides support with internal audits, second and third parties’ audits and inspections as required.
- Leads project team within functional area, as needed.
- Participates in cross-functional teams as appropriate for own functional area.
- Participates as required in training on different management systems affecting own area of work.
- Notifies manager of third parties compliance questions and issues.
- Performs other related duties and assignments as required and defined by management.
- Review and approve PQR for all products.
- Following up customer complaints according to cGMP guidelines.
- Following up recall process according to cGMP guidelines.
- Issue, Review, authorize and maintain the approved coding system through the organization.
- Investigates and handle the CAPA system.
- Develop, coordinate implementation, and monitor different management systems throughout the organization.
- Coordinate and respond to regulatory, client, and third party quality assessments.
- Ensure all documents are controlled and revised regularly.
|
