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von: Ctcon
Contract
Posted 5 days ago
Recruiter: Ashwini Shirvaikar
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 Managerfor a 12 months contract based in Basel.
QA GMP-GDP Auditor and Compliance Manager–6626-ASH
Main 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
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