Regulatory Skilled in Pharmacy/Medicines/Healthcare

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Location: Baden-Baden, Germany Job Sort: Full-time Wage: Aggressive, primarily based on expertise Years of Expertise: 5 to 7 years Qualification: M.Pharm in Pharmaceutical Science or Drugs We’re in search of a extremely certified Accountable Individual with in depth expertise within the pharmaceutical trade. The profitable candidate could have a powerful background in distribution or quality assurance and an intensive understanding of German and EU laws pertaining to pharmaceutical distribution, together with Good Distribution Observe (GDP) necessities. Day after day of the position Handle authorised actions and preserve correct high quality data. Deal with CAPA, deviations, SOP drafting, workforce coaching, and provider audits. Coordinate with producers and carry out recall operations promptly. Conduct provider and buyer audits in accordance with procedures. Guarantee common self-inspections and implement obligatory corrective measures. Approve ultimate disposition of returned, rejected, recalled, or falsified merchandise. Present high quality help for Distribution Operation evaluation conferences. Outline GDP high quality KPIs and evaluation high quality indicators, recommending actions for enchancment. Guarantee efficient temperature management of medicines and conduct temperature mapping. Implement and preserve annual GDP coaching programmes for all workers. Preserve High quality Technical Agreements for all outsourced actions and subcontractors. Guarantee compliance with EU GDP requirements for Parallel Import design and relabelling. Preserve documentation and licenses for processing. Necessities M.Pharm in Pharmaceutical Science or Drugs. Minimal 5 years of expertise in an analogous position throughout the pharmaceutical trade. Information of PLPI license, GDP Licences, EU-QPPV, RP. Robust information of Good Distribution Practices. Wonderful organisational abilities with consideration to element and accuracy. Robust interpersonal and communication skills. Skill to work independently and handle a number of priorities in a dynamic atmosphere.
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