Quality Manager TRD QA 3rd Party QA Management vacancy for a globally operating Basel based company in the pharmaceutical sector.
* 5+ years of experience in technical drug development, production, QC or QA
* Good knowledge of cGMP, working knowledge in technical development, production or QA as well as a sound scientific, technical and regulatory knowledge
* Organizational skills with the ability to execute project objectives through to completion and motivate others to complete deliverables and meet project expectations
* Proven ability to analyze and evaluate cGMP compliance
* Languages: English, fluent in written and spoken
* Being responsible for the evaluation of the compliance status, approval and oversight of Third Parties used in global TRD such as approves Third party Assessments or TA, approves list of Third Parties
* Handling the execution of risk assessments and performance tracking of Third Parties to allow continuous monitoring and early detection of negative trends, proposing remediation actions and escalating as required
* Managing establishment of Quality Agreements with Third Parties from supporting the negotiations to the final signature in alignment with the TA, audit reports and Health Authority requirements
* Leading and managing the creation and maintenance of SOPs and related documents and sets standards for global QA Third Party management such as SOPs and QA Agreement templates in combination with leading key initiatives in the global TRD Third Party Management work stream like Third Party Quality Risk Assessments, improvement projects and establishment of new processes
* Providing guidance and consultation to TRD Line Units in GMP compliance related issues focused on Third Party management and in areas of expertise such as TSE/BSE
Location: Basel, Switzerland
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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