Responsibilities
Generic activities
Support a discipline and / or provide a service individually or within a team of associates. May provide functional expertise to the corresponding business partner (Line Unit) and other QA Units in area of responsibility.
Write, review, decide on approval and / or release of GMP-relevant deliverables in order to ensure compliance with cGMP internal quality standards.
Perform project related activities, e.g. TRD products portfolio, operational processes, Quality Risk Assessments.
Support Project management functions as a project team member.
Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility.
Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
Specific tasks
Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation with the authority defined as per related governing SOPs, and with authorities delegated by the TRD Quality Team Head or QA Switzerland Site Head
Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up.
Write, review, and complete GMP relevant documents (e.g. CoAs, BRR checklists, SOPs, risk assessments).
Supports audits and inspections in case of questions on assigned projects
QA SPOC for assigned CMO. In this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements. Also responsible for collecting feedback from the various QA managers and support preparation of the Quality Risk Assess-ment. Is informed about deviations / OOX, general issues and changes at the CMO, and follows up at the corresponding meetings. Helps the QA managers and specialists for specific questions on CMO batch records / documentation and helps keeping harmonization of TRD QA Ops response.
Deputize for peers in the same area of responsibility
Qualifications and Experience
Swiss working / residency permit and / or Swiss / EU-Citizenship required
Master’s degree desirable
5 years’ experience in Pharma quality
Fluent German and English required (oral & written) for 1 role / / English Fluent and German nice to have for the second open role
Good knowledge of cGMP, working knowledge in technical development, production and QA
Sound scientific, technical and regulatory knowledge
Strong organizational and decision-making skills
Strong and proven ability to analyze and evaluate cGMP compliance
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