It infrastructure engineer állások, munkák minőségbiztosítás kategóriában

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...

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

• Master's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering or Law
• Native German speaker with strong English skills (C1)
• 3+ years of experience in GMP deviation & CAPA management
• Strong IT skills

• Lead and inspire a global team of about 30 scientists and technical experts, fostering innovation, collaboration, and excellence.
• Spearhead the formulation and manufacturing process development for small molecule animal health products, from enabling formulations to tech transfer.

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

Act as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Change Control and Risk Management within the EUCAN region....

• Regional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparency
• Drive standardization of the assigned system processes – both in the area of GMP and GDP
• Collaborate closely with the regional Business Process Owner