Technical QA Manager

vor 2 Wochen

Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
We are looking for a motivated and committed **Technical QA Manager** for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.

The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

**Tasks**:

- QA supervision of qualification
- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Basel
- Support of implementation of DI requirements
- Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
- Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
- Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
- Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
- Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements between Roche sites.
- Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
- Assistance is required in the introduction and training of new employees

**Must Haves**:

- Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent.
- Min. 5 years of Quality Management related experience in the Pharmaceutical industry.
- Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
- Sound understanding on current DI (Data Integrity) requirements
- Experience with MES (Manufacturing Execution System)
- Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP
- Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
- High expertise and experience in building and maintaining constructive and effective relationships with internal and external partners and stakeholders
- Strong team-player with a high level of self-motivation and being able to inspire others
- Ability to effectively influence others across all levels of the organization
- Strong collaboration across cultures, countries, technical competencies, and organizational levels
- Successful performance in health authority inspections and internal GMP audits
- Fluent German and English (spoken/written) is a must for this position

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