The Compliance Leader will be working as part of the Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP regulation.
The Compliance Leader will be working as part of the Quality Unit on site ensuring products are manufactured, stored and packaged in accordance with the cGMP.
Under the direction of the Head of Quality, he/she will be in charge to improve continuously the Quality system regarding the cGMP requirements. He/She will be a QA support in case of quality issues and problem solving techniques to assure the successful outcomes of company and external Health Authority.
He/She will be in direct contact with our customer in case of qualification audit, QA complaint issues and other quality topics.
1) Provide QA support for:
- Investigation and closure for the Deviation and the Out Of Specifications
- Change Control initiation and implementation
- CAPA initiation and implementation
- SOP and Policy writing in accordance with the cGMP and company policies
- Batch records reviewing and associated documents after production
- Control Cleaning Records
3) Continuous improvement and project support:
- CPB Improvement support and project leader for the new QA project (ex.: new system implementation)
- Actively contribute to continuous improvement initiatives
4) Customer relationship:
- Point of contact in case of customer audit
- Customer audit contact for the responses
5) Other activities:
- TrackWise System Administrator
- QA KPI implementation and follow-up.
- QA Trainer (GMP training, Quality issues training, new SOP/Policies,…)
- Work with relevant departments to ensure timely closure of quality actions
- Internal auditor
- Collaborate with the different departments to resolve compliance issues
- Back-up of the Head of Quality