Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a QA GMP-GDP Auditor and Project Manager for a 12 months contract based in Basel.QA GMP-GDP Auditor and Compliance Manager-6626-ASHMain Responsibilities:
Ensure GDP compliance of facilities.
Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation
Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement (QS document including Quality agreements with third parties
Administer systems to monitor (KPIs), track, and trend regulatory compliance (e.g. deviations, CAPA, investigations, complain, change control etc.)
Manage filing process and system for all quality documents
Support processes and procedures for document management in the EDMS
Establish External QA Audit and internal self-inspection frequency based on Risk Assessment, as appropriate. Prepare and/or participate to the annual audit plan
Establish and maintain an approved supplier list for GMP/GDP suppliers/service providers
Coordinate and conduct GMP / GDP audits and self-inspections; write corresponding audit reports
Promptly report critical self-inspection findings to the Responsible Person and management, as per SI procedure
Coordinate, plan and manage Regulatory Agency Inspections
Support preparation of Regulatory Agency Inspections
Notify management of potential quality and regulatory issues
Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant
Support optimization of Viatris' pharmaceutical quality system by preparing for the review of relevant Key Performance Indicators
Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones
Provide coaching and advise to Junior QA GMP/GDP Auditor and Project Manager when required
Qualifications and Experience:· Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum.
3-6 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
Experience in quality assurance of drug substance and/or drug product
Excellent knowledge of relevant GMP/GDP and international quality regulations: ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP
Ability to interpret and implement Quality standards
Ability to manage complex projects and prioritize workload according to the project importance
Ability to pro-actively initiate and lead quality compliance activities
Ability to manage multiple tasks with competing priorities
Good interpersonal and influencing skills
Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
Ability to communicate clearly and professionally both verbally and in writing
Fluent in English and at least basic knowledge of an additional European language, German or French advantageous
