Main Responsibilities :
* Ensure GDP compliance of facilities.
* Manage, review, and approve change controls, deviations, and CAPAs related to internal pharmaceutical operations facilities (not project specific).
* Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory documentation.
* Evaluate, develop, establish, and maintain internal processes and procedures for GMP/GDP compliance and process improvement (including QS documents and quality agreements with third parties).
* Administer systems to monitor (KPIs), track, and trend regulatory compliance issues (e.g., deviations, CAPA, investigations, complaints, change control).
* Manage filing system for all quality documents.
* Support document management processes in the EDMS.
* Establish external QA audit and internal self-inspection frequency based on risk assessment; prepare and participate in the annual audit plan.
* Maintain an approved supplier list for GMP/GDP suppliers and service providers.
* Coordinate and conduct GMP/GDP audits and self-inspections; prepare audit reports.
* Report critical self-inspection findings promptly to the Responsible Person and management, following SI procedures.
* Coordinate and manage regulatory agency inspections.
* Assist in preparing for regulatory inspections.
* Notify management of potential quality and regulatory issues.
* Monitor changes in quality regulations and initiate activities to ensure ongoing compliance.
* Support optimization of Viatris' pharmaceutical quality system by reviewing relevant KPIs.
* Participate proactively in quality system improvements by proposing new procedures, tools, or modifications.
* Provide coaching and advice to junior QA GMP/GDP auditors and project managers when required.
Qualifications and Experience :
* Relevant Swiss work/residency permit and/or Swiss/EU citizenship required.
* University degree in Pharmacy, Chemistry, or related scientific/technical field; master's degree minimum.
* 3-6 years of experience in pharmaceutical development, quality control, analytical development, chemical production, or similar roles in the industry.
* Knowledge of drug substance and/or drug product development, manufacturing, quality control, packaging, and distribution.
* Experience in quality assurance of drug substances and/or drug products.
* Excellent knowledge of GMP/GDP and international quality standards: ICH, ISO, WHO, PIC, FDA, EU GMP Guide, EU GDP.
* Ability to interpret and implement quality standards.
* Strong project management and prioritization skills.
* Proactive in initiating and leading compliance activities.
* Ability to handle multiple tasks with competing priorities.
* Good interpersonal and influencing skills.
* Self-confident, assertive, and autonomous in dealing with complex stakeholders and situations.
* Excellent verbal and written communication skills.
* Fluent in English; knowledge of an additional European language (German or French) advantageous.
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