Senior QC Scientist – Material Lifecycle

For our client active in the pharmaceutical industry, our team is looking for a Senior QC Scientist – Material Lifecycle

Location: Bern

Immediate availability

Duration of the mission: 7 months

Senior Manager Customer Audit

Main task :

The incumbent will play a key role in providing essential services and operational support within the QC department, as well as to external partners and clients. This position is crucial to ensure the release of materials in accordance with Good Manufacturing Practices (GMP) on site. It covers in particular the management of the introduction, qualification, and specifications of materials. In addition, the incumbent will lead or actively contribute to the introduction and continuous improvement of associated processes.

Main responsibilities:

• Ensure the introduction of manufacturing materials in accordance with GMP.
• Manage the release of incoming purchased materials (MIC and UD) in compliance with GMPs and deadlines.
• Review analytical data, including work authorization in LIMS and certification of test results, to ensure its compliance and integrity.
• Manage the management of discrepancies, out-of-scope results (OOS) and change control processes.
• Maintain a constant state of readiness for audits and inspections, by actively participating in customer audits and regulatory inspections.
• Independent review and certification of raw data (including internal and external certificates of analysis).
• Perform the review of analytical data in LIMS, including work authorization and certification of results, ensuring their compliance and integrity.
• Participate in simulated audits (MOCK audits).

Profile :

• Minimum 5 years of experience in an industry subject to Good Manufacturing Practices (GMP).
• Previous experience within a globally operating company
• At least 2 years of practical experience in pharmaceutical quality control and/or quality assurance.
• Mastery of deviation management processes, change control and corrective and preventive actions (CAPA).
• Excellent ability to collaborate with multidisciplinary teams to achieve project objectives and ensure optimal results.
• Fluency in English required; German would also be a strong asset.
• Demonstrated competence in the use of ERP software, such as SAP, appreciated.
• Strong understanding of GMP regulations and compliance standards.
• Excellent technical writing skills for accurate documentation and reporting
• Ability to work independently according to internal procedures, with rigorous documentation.
• Rigorous, precise and reliable work method.
• Very good command of Microsoft Office tools.
• Availability for occasional travel (up to 10%)

GI LIFE SCIENCES CONTACT :

Jessica Liuzzo : Write an email