Qualified Person Market Release Europe
il y a 2 semaines
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Qualified Person Market Release Europe, LimburgClient:
Sharp Services
Location:Limburg
Job Category:Other
EU work permit required:Yes
Job Reference:ff9d4502fa7c
Job Views:2
Posted:06.03.2025
Expiry Date:20.04.2025
Job Description:To strengthen our team, we are recruiting for a:
Qualified Person Market Release Europe
The Qualified Person Market Release Europe is responsible for managing an operating model for realizing QP Services and QP Market Releases to Customers of Sharp EU. This person will also maintain and improve the operating model for providing such QP Release Services both for commercial pharmaceutical products as for IMP's. This key position will work with the Sharp network of internal and external QP's as well as with the 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. The Qualified Person Market Release Europe will report to the QA/RA Manager for Sharp Europe.
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 QP's.
- 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 QP's 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 as described in article 53 of Directive 8001/82/EC; i.e. in possession of a Master degree, industrial pharmacist, completed with relevant training and courses.
- Eligible to be responsible pharmacist and Qualified Person for Enestia Belgium N.V., as in the Belgian Royal Decree of 6 June 1960 and according to the requirements of FAHMP.
- Eligible to be Qualified Person for MPF Netherlands or EPC Production and in alignment with Dutch law (Geneesmiddelenwet) and according to the requirements of IGJ and Farmatec.
- 5 years of experience in a QP role for pharmaceutical manufacturing, 5-10 years of experience in a supervising QA role.
- Active and in-depth knowledge on international cGMP guidelines and pharmaceutical regulations.
- Knowledge of Medical Device Regulations and of Healthcare Regulations.
- Good working knowledge of Pharmaceutical API manufacturing, formulation, filling, packaging.
- Good working knowledge of Pharmaceutical Biotech manufacturing.
- Decision maker.
- Ability to motivate and lead colleagues at Sharp.
- Positive mindset and solution driven.
- High standards of integrity.
- Proven ability to plan resources and manage priorities.
- Willing to travel.
At Sharp, we strive to create a work environment where all employees can make the most of their skills. We offer you a versatile and challenging position in a dynamic working environment and we create numerous career opportunities. You can count on a suitable salary that is supplemented with numerous benefits, such as:
- A job with a lot of variety.
- Working at an international organization with nice colleagues.
- Clean working environment.
- Travel allowance from 10 km.
- Work from home allowance.
- Internet allowance when working from home.
Interested? Apply with resume and cover letter | Contact: Larissa Piebenga | Neptunus 12 8448 CN Heerenveen | T + 31 6 46 60 09 47 | Present on Monday, Tuesday and Thursday.
Or apply via Workday (Job Hub > Browse Jobs > Primary Location > Heerenveen > apply > add resume and cover letter).
External: visit our Career Page and apply via Workday.
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