Documentation and Compliance Manager (f/m/d)

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Ver: 154

Dia de atualização: 21-03-2024

Localização: Basel Basel-Stadt BS

Categoria: Legal / Contratos

Indústria: Research Services

Posição: Mid-Senior level

Tipo de empregos: Contract

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Conteúdo do emprego

Documentation and Compliance Manager(f/m/d) -Pharmaceutical/documentation/ project management/GMP/agileProjectFor our customer a big pharmaceutical company in Basel we are looking for a highly qualified Documentation and Compliance Manager.BackgroundWithin the department, the chapter Product Care/Documentation and Compliance is accountable for Technical Support of marketed Combination Products and Medical Devices, Post Launch Changes, Complaints and DHF Maintenance, input to APQR/PSQR, Remediation’s. The Documentation and Compliance activities include the departmental training concept and onboarding of new employees, SPOC for PQS and Quality systems, departmental archiving concept, records & data management and coordination of self inspections/audits.The Perfect CandidateThe perfect candidate has a degree within life sciences and at least 5 years of relevant experience in compliance management and documentation within the pharmaceutical industry. Additionally, the candidate is someone who wants to influence his/her own development and can work independently, with limited supervision. The person is looking for a company where they have the opportunity to pursue their interests across functions and geographies.Tasks & Responsibilities- Act as a commercial complaint investigation support, evaluate the annual complaint analysis and support follow up activities, for example, Root Cause Investigations, subsequent Corrective Action and Preventative Actions (CAPA) and Change (Technical Change Management, Transfers, Capacity Expansion).
  • Support or lead technical Changes eg Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
  • Manage the Product Care Annual Review (PCAR)
  • Ensuring regulatory compliance and Roche internal GMP standards (eg departmental archiving concept, records management and training)
  • Interpret Pharma Quality System requirements into local operational processes
  • Support internal/external Quality/Regulatory/SGU inspections
  • (Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertise
  • Continuous optimization of performance and striving for excellence
  • Manage Onboarding of new employees and manage training system
Must Haves- Bachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area)
  • 5 min. year proven track record of compliance management and documentation in the pharmaceutical or related industry
  • Min. 5 years demonstrated track record in project management
  • Strong GMP Knowledge
  • Excellent communication and negotiation skills in German and English with success in building trustful relationships
  • Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions
  • Self-motivated, pro-active, responsible, result-oriented and an excellent team player
  • Experience in working in agile environment and usage of lean tools
Reference Nr.: 922382SKNRole: Documentation and Compliance ManagerIndustrie: PharmaWorkplace: BaselPensum: 100%Start: 01.03.2023Duration: 12Deadline: 10.02.2023If you are interested in this position, please send us your complete dossier via the link in this advertisement.About UsITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.
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Data limite: 05-05-2024

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