As solution provider within the Life science sector , XPE Pharma & Science is looking for a Compliance Leader for a Pharma client in Brussels!
As Compliance Leader you will be working as part of the Brussels Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP regulation.
You 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, you will be in charge to improve continuously the Quality system regarding the cGMP requirements. You also 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.
Principle Responsibilities of your job :
• 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 Corden Pharma Policies
- Batch records reviewing and associated documents after production
- Control Cleaning Records
• 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
• Customer relationship:
- Point of contact in case of customer audit
- Customer audit contact for the responses
- Customer audit contact for all question regarding the Corden Pharma Brussels compliance aspect
• 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
Key Competencies Necessary to Effectively Perform this Job
Minimum qualifications: Master degree Sciences
• Professional experience required: Min.10 years in a QA position
Specific skills required:
• Perfect knowledge of cGMP in a regulated environment (ICH guidelines)
• Knowledge of quality systems in cGMP environment (21 CFR part 11)
• Excellent accuracy and attention to detail
• Excellent interpersonal skills (Team spirit, Open for the constructive discussion,…)
• Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset
• Strong problems solving skills, issue resolution and root cause analysis
• Knowledge in Lean Tools is an asset
• Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
• Language: French, English
• An exciting experience in leading pharmaceutical company;
• An attractive salary package with company car and extra-legal advantages;
• A fix term contract.
Asmae El Addad