Senior Quality Assurance Officer - GDP (12 month FTC)

Norgine

  • Amsterdam, Noord-Holland
  • Vast
  • Voltijds
  • 15 dagen geleden
  • Versneld solliciteren
Want a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.We have an exciting opportunity for a Quality Assurance Officer to join Norgine.The person holding this position will report to the Distribution Quality Assurance Manager. The core responsibility of the role is to support Distribution Quality in ensuring Good Distribution Practices (GDP) are followed. Work with Responsible Persons (RP) across the distribution network to provide support and guidance on quality and regulatory issues. Maintain, support and improve the Quality Management System employed across the Norgine distribution network, whilst maintaining compliance with regulations and standards for medicinal products and medical devices.This is a temporary 12-month assignment.KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Provide support and leadership to the Global Distribution Quality team for ongoing operations and business project deployment in a compliant effective manner.
  • Act as the Quality lead in assigned projects
  • Complete tasks in a timely manner or escalate issues to line management
  • Act as a point of contact for queries from internal and external sources (service providers and distributors).
  • Support in planned improvement projects and ad-hoc improvement projects as required.
  • Support the GDP audit universe.
  • Create, negotiate and maintain Quality Agreements with partners and distributors
  • Author Quality Agreements
  • Participate in the Norgine GDP audit programme
  • Conduct GDP compliance audits (internal & external)
  • Identify & report quality risk and propose risk mitigation/ remediation plans with partners. Ensure the risk is reported and managed in appropriate manner to minimise impact on patient supply or to the Business.
  • Conduct risk assessments
  • Take actions to reduce risks to an acceptable level
  • Identify and report risks that are beyond local resources to remediate
  • Provide support with regards CAPA management, for deviations and investigations for significant quality events. Review, evaluate, and contribute to investigation into OOS or major deviations that are identified and follow-up on corrective actions associated.
  • Raise deviations and CAPA and ensure close out or escalation
  • Appoint and or conduct investigations, ensuring root cause is determined and CAPA identified
  • Close out investigations and CAPA by providing Quality Assurance concurrence
  • Support coordination of Inspection Readiness activities to ensure adherence to the applicable internal and external standards of compliance at all times.
  • Organise and coordinate site inspection readiness to ensure GDP compliance
  • Host and or support external competent authority inspections as part of RP role
  • Act as Responsible Person (RP) on Norgine Wholesale Distribution licence, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
  • Keeping appropriate records of any delegated duties and activities
  • Act in capacity to performed delegated duties concerning Norgine WDA licences
  • Ensuring that suppliers and customers are approved
  • In case a recall for medicinal products is deemed necessary, promptly perform any necessary operation
  • Ensuring that self-inspections are performed at appropriate relevant intervals following a pre-arranged programme, participate in GDP self-inspections and ensure necessary corrective measures are put in place
Requirements
  • Scientific Degree with a professional qualification
  • Responsible Person qualification and status required.
  • Experienced and qualified GDP auditor
  • Solid experience in a Quality environment in the pharmaceutical industry with a sound Knowledge of GDP
  • Experienced in supporting successful regulatory inspections.
  • Good knowledge of regulatory requirements impacting the pharmaceutical and medical device industries, in particular the pharmaceutical distribution environment with good knowledge of GMP/GDP.
  • Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine or distribution partners.
  • Excellent verbal and written communication skills ability to present effectively to groups
  • Proven ability to make science based, data driven recommendation/decisions and take appropriate action.
  • Attention to detail
  • Influencing skills
RELATIONSHIPS:
  • Member of Distribution Quality team, reporting to the Distribution Quality Assurance Manager.
  • Maintains excellent working relationships with all Norgine manufacturing sites and distribution quality organisation
  • Liaise with distribution service providers and Norgine partners.
Key Committee Memberships:
  • Business and Quality review meetings with service providers or partners
  • Supporting the Global Distribution Quality Council (GDQC)
BenefitsOur benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.Sound good? Find out more about the career you’ll have with Norgine, then apply here.#LI-PP1

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