Quality Specialist

Main Responsibilities

• Support a discipline and / or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
• Write and review GMP-relevant deliverables and / or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance’s, SOPs etc.).

• List individual specific activities (e.g. : as described in SOP QA Approval and Release responsibilities / authorities)
• Receives incoming documents (e.g. executed batch records, vendor labels, etc.).
• Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.
• Scan, file and archive documents owned by QA. (e.g. Certificate of Compliance, Batch Record Review Checklists).

• Relevant working / residency permit or Swiss / EU-Citizenship required
• Bachelor's or Master’s degree in Science. Technicians with 5 years of experience also OK
• Bachelor’s with 3 years of experience
• Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
• Scientific, technical and regulatory knowledge in a specific area.
• Basic knowledge of drug development.
• Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
• Good organizational skills
• Fluency in English