Documentation and Compliance Manager

Vor 2 Tagen


Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Documentation and Compliance Manager** for a temporary contract of 12 months with a possible extension.

Within 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.

**Tasks**:

- 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 e.g. 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 (e.g. 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



  • Basel, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...


  • Basel, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...


  • Basel, Schweiz Swedish Orphan Biovitrum Vollzeit

    **Role & Function** The Documentation and Administrative Manager will be responsible for providing the necessary support for documentation and administrative management of activities within PDTM to support development and geographic expansion of drug products. **Key Responsibilities** - Ensure mapping and filing of PDTM documentation (internal & external...


  • Basel, Schweiz Sobi Vollzeit

    **Documentation and Administrative Manager** The Documentation and Administrative Manager will be responsible for providing the necessary support for documentation and administrative management of activities within PDTM to support development and geographic expansion of drug products. **Key responsibilities** - Ensure mapping and filing of PDTM...


  • Basel, Schweiz NTT DATA Vollzeit

    **Req ID**: 258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...


  • Basel, Schweiz Hashmap Vollzeit

    **Req ID**:258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...


  • Basel, Schweiz Halian Vollzeit

    Job ResponsibilitiesEnsure GMP compliance at third party service providers and within internal facilities.Lead or assist in establishing external QA Audit and internal self-inspection annual Plan.Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations.Promptly...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **_The Life Science Career Network_** **QA Auditor Compliance Manager** Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized...


  • Basel, Schweiz Apsida Life Science Vollzeit

    Apsida Life Science is looking for a QA Compliance Manager.Key Responsibilities:Ensure compliance with GMP standards at both third-party service providers and internal facilities.Develop and assist with the annual plan for external QA audits and internal self-inspections.Conduct GMP/GDP audits and self-inspections, coordinating with internal teams and...

  • Compliance Manager

    Vor 6 Tagen


    Basel, Schweiz True Wealth AG Vollzeit

    True Wealth is the Swiss pioneer in online wealth management. Already over 10,000 clients entrust their assets to our investment solution and we are constantly developing our platform to make investing ever simpler, transparent and more cost effective. We pass on the advantages of digitalisation to our customers, enabling them to invest, and provide for...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    QA Auditor Compliance Manager – 6263 ADAOur 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 for a QA Auditor Compliance Manager for 1 year contract with high possibility of extension based in...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    QA Auditor Compliance Manager – 6263 ADAOur 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 for a QA Auditor Compliance Manager for 8 month-contract based in Basel, Switzerland.Main...


  • Basel, Schweiz Evergreen Theragnostics Vollzeit

    Direct message the job poster from Evergreen TheragnosticsVice President Human Resources | Senior Human Resources ProfessionalClinical Quality Assurance (QA) Manager and AuditorEvergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own...


  • Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...


  • Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    Randstad is seeking a highly skilled Pharmaceutical Quality Compliance Specialist to support and own Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections.Job OverviewThe successful candidate will work closely with QC-Capability Leads (QC-CLs) to maintain and improve compliance within our IMP QC operations. The...


  • Basel, Schweiz Sobi group Vollzeit

    Quality Engineer and GxP e-Compliance SpecialistFull-timeSobi Location: SwedenStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, the...


  • Basel, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) Vollzeit

    Quality Engineer and GxP e-Compliance SpecialistCompany DescriptionAt Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease...


  • Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel - Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...


  • Basel, Schweiz Coopers Group AG Vollzeit

    Contract and Process Manager For our Pharma client based in Basel, we are looking for a dynamic and experienced **Contract and Process Manager** **Background**: Our client is looking for a Contract & Process Manager to join the Medical Affaire Team to support them with the increased workload. In this position, you will need to be able to work...


  • Basel, Schweiz Sobi group Vollzeit

    Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, the work we do every day redefines the standards of care and transforms the lives...