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Compendial Compliance Specialist, Ringaskiddy
Client: Eurofins Ireland PSS
Location:
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
a3cf2d1788d1
Job Views:
4
Posted:
23.01.2025
Expiry Date:
09.03.2025
Job Description:
The main purpose of the Associate Scientist - Compendial Compliance role will be to support the BTDS-AD team in Compendial Compliance acting as Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.
Job Responsibilities
* Subject Matter Expert: Act as a Large Molecule, Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.
* The scope of the methods encompasses methods such as - pH, Color, Turbidity, Osmolality, Moisture, Extractable Volume, Visible Appearance, Sub-Visible Particulates and MDI.
* Clinical Product Lifecycle Management: Lead/deliver the clinical product lifecycle management from Phase I-III with regards to product presentation and formulation changes and manage the co-ordination of the demonstration of method robustness. Support the clinical to commercial product transition in relation to method/instrumentation performance and laboratory investigations, as applicable.
* Regulatory Filings: Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.
* Ability to advance and shape the BTDS AD Cork technical analytical capabilities in-line with industry standards.
Qualifications
* A degree or diploma in chemistry or a related discipline
* 3rd Level qualification in science, administration or other relevant disciplines is preferable
* 3 years’ experience in a relevant testing/Compendial role
* The successful candidate will be a motivated self-starter, capable of working under their own initiative
* Excellent interpersonal and verbal and written communication skills are essential for this role.
Additional Information
* This is an opportunity to join Eurofins on a full-time permanent basis.
* Working a flexible 39 hour week.
* Benefits of pension contribution, medical insurance, health insurance and bonus are included in package.
* Eurofins Management and Team on client site for support.
* Opportunity to get to know fantastic people and be part of a great team.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
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