Qc Lead
Il y a 5 mois
**Company Description**
At AbbVie Liège Odyssea Pharma, we work on woman health through an innovating intra-uterine device system.
Our site is a production site that aim to deliver a high-quality product to our customers. However, as a small site we focus on keeping a strong collaborative mindset through all departments and teams.
We are currently looking for a **QC lead / supervisor role** to be part of our dynamic quality control team.
**Qualifications** Job Responsibilities**:
- Ensures the continuing training of technicians.
- Participate in the planning of activities (analyses, samples, etc.) to be carried out within the laboratory.
- Participate in internal and external projects.
- Support internal/external audits as an SME
- Review the analysis files and rule on the conformity of the results with the specifications.
- Manage events occurring in the laboratory (during analyses, etc.)
- Guarantee the sampling and control of stabilities, products (finished/semi-finished)
- Supervises activities related to environmental control.
- Participate in investigations and in the drafting of reports (LIR, deviation, etc.)
- Perform trend analyses, calculate KPIs
- Guarantee that all operations carried out by the QC department comply with internal quality requirements.
- Monitor and collaborate with analytical subcontractors.
- Ensures the maintenance and qualification of equipment and premises in the QC department.
- Ensures that master data is maintained in the LIMS.
- Ensures that the sample library is maintained.
**Qualifications and Skills**:
- Bachelor with scientific orientation with minimum 6 years of experience in QC in the pharmaceutical industry or Master with scientific orientation with minimum 4 years of experience in the Chemical/Pharmaceutical industry or Ph.D. with scientific orientation with minimum 2 years of experience in the Chemical/Pharmaceutical industry.
- Very good knowledge of English (oral and written B2)
- Knowledge of GMP (EU and US), EP and USP, ICH guidelines, EudraLex
- Very good concept of Office suite
- Leadership and Team Management
- Project management is an asset.
- Validation of equipment/methods is an asset.
- Knowledge of data management systems such as LIMS or equivalent
**Additional Information
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