Regulatory Compliance Specialist for Pharmaceutical Release Services

4 dagen geleden

Heerenveen, Friesland, Nederland Sharp Services Voltijd
Job Description

The Regulatory Compliance Specialist will be responsible for managing an operating model for realizing QP services and QP market releases to customers of Sharp EU. This individual will also maintain and improve the operating model for providing such QP release services both for commercial pharmaceutical products as for IMPs.

This key position will work with the Sharp network of internal and external QPs as well as with business leaders of the Sharp Division to maintain and further build a sustainable and profitable operating model of QP services and batch releases to European markets or to testing sites for clinical trials.

Responsibilities
  • Maintain a profitable operating model for the provision of batch release to market services, adapt and improve this model where appropriate, in alignment with regulatory requirements.
  • Maintain and extend the network of internal and external QPs.
  • Map knowledge of API and pharmaceutical bulk production and processes.
  • Familiarize with customers' supply chains and assess the need for ensuring full oversight of customer's supply chains.
  • Ensure full oversight of the Quality Management System of all players in the customer's supply chains; build and maintain a working model to ensure and maintain such oversight.
  • Ensure full responsibility for all stages of manufacture and testing of a batch or put systems in place where such full responsibility can be shared with other QPs who have provided confirmation for specified steps in the manufacture and control of a batch.
  • Decide on batch disposition of materials and final finished product in line with Annex 16 to the EU Guide to Good Manufacturing Practice Title: Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.
  • Ensure that all points stipulated in article 1.7. of Annex 16 to the EU Guide to Good Manufacturing Practice are secured.
  • Build a model whereby GMP assessments by third parties (such as audits) can be relied upon.
  • Act as auditor/lead auditor during audits of manufacturing and testing sites within the customer's supply chain.
  • Handle unexpected deviations throughout the supply chain; evaluate if these deviations are in line with the market authorization and assess the impact and the need for the submission of a variation to the market authorization and for including affected batches in the ongoing stability program.
  • Work with the sites of Sharp EU to ensure full collaboration between the operational teams and the department performing QP release to market services.
  • Evaluate and approve Changes where needed and appropriate.
  • Review and approve final investigation reports on incidents, complaints and investigations.
  • Ensure that each batch has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorization.
  • Provide training to other employees by demonstration, repetition, modelling, large group training, etc.

  • Qualified Person Market Release Europe

    1 maand geleden

    Heerenveen, Friesland, Nederland Sharp Services Voltijd

    Job Title: Qualified Person Market Release EuropeWe are seeking a highly skilled and experienced Qualified Person Market Release Europe to join our team at Sharp Services. As a key member of our regulatory affairs team, you will be responsible for managing the operating model for realizing QP Services and QP Market Releases to Customers of Sharp EU.Key...

  • EHS Specialist with Regulatory Compliance Expertise

    6 dagen geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    At Zebra, we're shaping the future of work on the front line—reinventing how businesses run and move society forward.About the RoleThe Environmental Health and Safety (EHS) Specialist plays a critical role in ensuring our organization's compliance with federal, state, and local regulatory requirements. As an EHS Specialist, you'll be responsible for...

  • Computer Systems Validation Specialist

    1 maand geleden

    Heerenveen, Friesland, Nederland Sharp Services Voltijd

    Job Title: Computer Systems Validation SpecialistWe are seeking a highly skilled Computer Systems Validation Specialist to join our team at Sharp Services. As a CSV Specialist, you will play a crucial role in ensuring the quality and integrity of our IT systems.Key Responsibilities:Develop and implement validation protocols for IT systems to ensure...

  • Environmental Sustainability Specialist

    3 dagen geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    At Zebra, we are shaping the future of work on the front line—reinventing how businesses run and moving society forward.About UsWe develop new technologies and create new solutions with partners to help organizations act with greater visibility, connectivity, and intelligence—delivering better experiences for workers and those they serve.Job...

  • Environmental Health Specialist

    1 week geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    Job SummaryZebra is seeking a highly skilled Environmental Health and Safety Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements, implementing and standardizing Environmental, Health and Safety efforts across all designated sites, and developing and executing programs...

  • Environmental Health Specialist

    4 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    Job Title: Environmental Health SpecialistAt Zebra, we are seeking a highly skilled Environmental Health Specialist to join our team. As a key member of our EHS department, you will be responsible for ensuring compliance with federal, state, and local regulatory requirements.Key Responsibilities:Coordinate with facilities representatives, site leaders, and...

  • Computer Systems Validation Specialist

    1 maand geleden

    Heerenveen, Friesland, Nederland Sharp Services Voltijd

    Job Title: Computer Systems Validation SpecialistWe are seeking a highly skilled Computer Systems Validation Specialist to join our team at Sharp Services. As a CSV Specialist, you will play a crucial role in ensuring the quality and integrity of our IT systems.Key Responsibilities:Develop and implement validation protocols for IT systems to ensure...

  • Senior Software Engineer for DevOps and Cloud Services

    2 weken geleden

    Heerenveen, Friesland, Nederland Synsel Voltijd

    About the RoleAs a Senior Software Engineer for DevOps and Cloud Services, you will be responsible for designing, implementing, and maintaining scalable and reliable cloud-based systems. This includes managing cloud infrastructure, automating deployment and scaling, and ensuring high availability and security.Key ResponsibilitiesDesign and implement...

  • Environmental Health Specialist

    3 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    At Zebra, we are shaping the future of work on the front line by developing new technologies and creating new solutions with partners to help organizations act with greater visibility, connectivity, and intelligence.The Environmental Health Specialist is responsible for coordinating with facilities representatives, site leaders, or plant managers to achieve...

  • Environmental Health Specialist

    4 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    At Zebra, we're shaping the future of work on the front line by developing new technologies and creating innovative solutions with partners to help organizations act with greater visibility, connectivity, and intelligence.The Environmental Health and Safety Specialist plays a critical role in ensuring compliance with federal, state, and local regulatory...

  • Environmental Health Specialist

    2 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    At Zebra, we are seeking an Environmental Health Specialist to join our team. In this role, you will be responsible for ensuring compliance with federal, state, and local regulatory requirements across various EHS disciplines.Key Responsibilities:Coordinate with facilities representatives, site leaders, and regional EHS staff to achieve predetermined goals...

  • Environmental Health and Safety Specialist

    2 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    Job Summary: We are seeking an experienced Environmental Health and Safety Specialist to join our team at Zebra. The successful candidate will be responsible for ensuring compliance with federal, state, and local regulations, as well as implementing and standardizing EHS efforts across our designated sites. Key responsibilities include measuring and...

  • Environmental Health Specialist

    3 weken geleden

    Heerenveen, Friesland, Nederland Zebra Voltijd

    Remote Work: HybridOverview:Zebra is shaping the future of work on the front line by reinventing how businesses run and moving society forward. We are a community of changemakers, innovators, and doers who come together to deliver a performance edge to the front line of business.We develop new technologies and create new solutions with partners to help...

  • Computer Systems Validation Specialist

    1 maand geleden

    Heerenveen, Friesland, Nederland Sharp Services Voltijd

    Job Title: Computer Systems Validation SpecialistWe are seeking a highly skilled Computer Systems Validation Specialist to join our team at Sharp Services. As a CSV Specialist, you will play a crucial role in ensuring the quality and integrity of our IT systems.About the RoleAs a CSV Specialist, you will be responsible for validating IT systems that impact...

  • Mechanical Design Specialist

    4 weken geleden

    Heerenveen, Friesland, Nederland Tetra Pak Voltijd

    Make a Difference at Tetra PakWe are committed to making food safe and available, everywhere. Our mission is to protect what's good – people, the planet, and the food we eat. Join us in our pursuit of excellence and become part of a team that touches millions of lives every day.Job SummaryAs a Mechanical Engineer at Tetra Pak, you will play a crucial role...

  • Technisch Specialist

    4 weken geleden

    Heerenveen, Friesland, Nederland SPIE Industry Services Voltijd

    Bij SPIE heb je niet zomaar een baan, maar een carrière.Als Technisch Specialist bij SPIE Industry Services ben je specialist op het gebied van elektrotechniek en besturingstechniek. Je werkt zelfstandig of in een team bij de klant op locatie, waar je diverse opdrachten uitvoert. Door de verscheidenheid aan klanten waarvoor je werkt, doe je veel kennis en...

  • Security and Compliance Specialist

    4 weken geleden

    Heerenveen, Friesland, Nederland Accell Group Voltijd

    About the RoleThe Security & Privacy Officer will play a key role in defining and driving the Information Security & Privacy strategy, policies, and maturity for Accell Group. As a recognized Information Security expert, you will provide input and help drive the strategy, working closely with the CISO, Security & Privacy Officers, the Legal team, and...

  • Marketing Specialist

    2 weken geleden

    Heerenveen, Friesland, Nederland Timing Voltijd

    Key Responsibilities:• Develop and execute marketing strategies to promote the company's products and services.About the Role:We are seeking a skilled Marketing Specialist to join our team. As a Marketing Specialist, you will be responsible for creating and implementing marketing campaigns to increase brand awareness and drive sales.What You'll Do:•...

  • Technisch Specialist: Elektrotechniek en Besturingstechniek Specialist

    2 weken geleden

    Heerenveen, Friesland, Nederland SPIE Industry Services Voltijd

    Technisch Specialist bij SPIE Industry ServicesWij zijn een bedrijf dat niet gewoon is. Wij richten ons op oplossingen in de productieomgeving van onze klanten en bieden een afgewogen dienstenpakket aan onze klanten, gericht op preventief onderhoud en storingen. Onze teamleden zijn ambitieus, slim en collegiaal.Onze verwachtingen- Je bent specialist op het...

  • Technical Support Specialist

    2 maanden geleden

    Heerenveen, Friesland, Nederland Riverty Voltijd

    Riverty is building the most human-centric fintech to enable everyone's future financial growth. We're looking for a Technical Support Specialist to join our team in Amsterdam or Heerenveen.About the RoleAs a Technical Support Specialist, you'll be part of the Tech Ops Support team, working closely with internal and external stakeholders to provide...