- Release and rejection of pharmaceutical products:Independent release of bulk and finished products (plasma products and aseptically produced products)Quality and safety of pharmaceutical products on the market.Is authorised to reject batches of finished product, intermediate product or raw materials for use if there is doubt as to their quality.Independently approving validation and project plans, processes, procedures and specifications
- Assessment and adviceAssessing change control requests and incident investigation after deviationsEnsure the correct compilation of the Batch Manufacturing Records, including test records of all productsHandling of external complaints and subsequent corrective actionsIndependent recall actions where necessaryAdvising the management and/or product and/or account managers on all issues relating to release and product quality(Co-)assessing new or modified registration file partsMonitoring file complianceCarrying out (external) inspections with regard to compliance with procedures that are relevant to the quality and reliability of the productsIs jointly responsible for the training of staff in compliance with applicable GMP/GDP guidelinesProvides specific reports at the request of the customer (e.g. PQR reports)
- Maintaining and/or obtaining pharmaceutical licenses
- Act as a Responsible Person; RP) in the context of GDP (Article 36(1) of the Medicines Act)
- Experience of at least 5 years of relevant work experience within the pharmaceutical industry.
- Masters degree in required field, like (bio)pharmaceutical sciences, biochemistry or similar
- Possibility to act as Responsible Person; RP) in the context of GxP
- Knowledge of biotechnological products and production processes.
- Knowledge of legal standards, quality standards and regulations within and outside the EU.
- You have strong analytical skills
- You are communicative
- Decision-making and resolutive attitude
- You speak English (Fluent) and Dutch (preferable)
- Full-time employment
- 8.33% end of year bonus and 8.33% holiday allowance
- Flexible working hours in consultation
- Personal training budget of €2,000 per 3 years
- Contribution to travel expenses from the first kilometer
- Good accessibility by public transport and private parking
- Pension plan at Zorg & Welzijn
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Qualified Person - Amsterdam, Nederland - Prothya Biosolutions
Beschrijving
As a Qualified Person/Responsible Person (QP/RP), you are responsible for ensuring that our products are released in accordance with applicable laws and regulations. You also ensure the safe distribution of medicines. Specifically, you can say that as a QP you assess whether raw materials, intermediate products and end products can be released and you release them if possible. As a QP you ensure the safe distribution of Prothya products and purchased products (merchandise) in accordance with GDP requirements.
Responsibilities:
Your profile:
Where you will work
Prothya Biosolutions is one of the few end-to-end pharmaceutical companies in the Netherlands. Our production process goes through all steps from raw material to filled and packaged end product. The production process meets the highest requirements as laid down in the GMP. Quality and safety are regularly checked by Dutch and international authorities.
What we offer
