Senior Scientist Biochemical Quality Control
vor 2 Wochen
For our partner located in the canton of Bern, GI Life Sciences is looking for a:
Senior Scientist Bio-/Chemical Quality Control
Start : Mid-November
End :
Your Mission :
As a
Senior Scientist in Bio-/Chemical Quality Control
, you will play a key role in establishing the BCQC unit within the company. You will ensure that processes comply with GMP requirements, participate in the transfer and validation of analytical methods, and actively contribute to preparing the department for regulatory inspections.
Your mission also includes managing QC projects and coordinating resources to guarantee adherence to timelines and quality standards.
Your Responsibilities :
- Develop, transfer, and validate analytical methods for finished products, in-process controls, raw materials, and cleaning samples.
- Draft and revise SOPs, work instructions, and protocols.
- Ensure full compliance of documentation.
- Oversee qualification, calibration, and maintenance of analytical equipment and infrastructure.
- Lead internal and external projects.
- Plan and coordinate daily QC team tasks, ensuring resource availability.
- Facilitate effective communication among stakeholders and monitor KPIs.
- Ensure compliance with GMP requirements, quality policies, and EHSS rules.
- Mentor and train QC colleagues, support recruitment, and foster team development.
- Guarantee traceability of analytical data and resolve quality-related issues.
- Promote continuous improvement initiatives and a strong quality culture within the department.
Your Profile :
- Scientific background (chemistry, biochemistry, pharmacy, or related field) with proven experience in Quality Control within a GMP environment.
- Expertise in analytical methods, validation, equipment qualification, and documentation management.
- Strong skills in project management, team coordination, and cross-functional communication.
- Knowledge of regulations related to controlled substances and international quality standards.
- Proficiency in IT tools (SAP, LIMS).
- Fluent in English (German is an asset).
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