Method Development & Validation Specialist

Co Cork
Permanent
Part-time

16 days ago

Company Description****We have an opportunity for a Method Development & Validation Specialist to join our PSS Site in Currabinny.****Consider joining Eurofins PSS® where people are the most important element in our business. Eurofins PSS® is the global leader of scientific insourcing services. PSS® is not only a leader in the industry, but also one of the first insourcing service providers, now celebrating over 15 years of service in Ireland and over 22 years of service globally.For more information about Eurofins PSS® please visit our and watch a from our Global Head, Beth Di Paolo.We currently have exciting opportunities to join our innovative and multi award-winning Professional Scientific Services (PSS) teams. The excellent service provided via our PSS model is delivered while maintaining the same commitment to excellence, expertise and cGMP compliance available at our Eurofins facilities.What can Eurofins offer you as an employee of ours?

Developmental opportunities and career progression
The opportunity to work with our client - a world -leading pharmaceutical and biotechnology company
Location is easily accessible
Private Medical Insurance
Income protection and life assurance
Annual discretionary bonus
Free parking onsite
Full use of the canteen facilities on the client site
Additional annual leave days with continued service
The opportunity to work on products helping to save lives across the world

Job DescriptionThe primary purpose of this role will be to develop and optimise analytical methods along with method validation and transfer according to regulatory guidelines. The role will involve participating in a Professional Scientific Services (PSS) team to ensure the highest quality and productivity standards are met along with the agreed client requirements and timelines.Job Responsibilities

Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data is adhered to.
Support innovative development of new analytical methods as well as improvement and optimization of current methods.
Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.
Lead in troubleshooting analytical technical challenges during the development, validation/qualification and transfer of methods.
Communicate regularly with client, providing updates on projects progress, addressing technical queries and delivering client project requirements to the defined timelines.
Ensure the delivery of projects in the required timeframe and ensure that the site's technical, quality and safety metrics are all achieved.
Provides suitable training where required to adopt new practices.
Review and approve standard operating procedures (SOP's), laboratory methods, control of substances hazardous to health (COSHH) assessments, laboratory investigational reports, validation protocols, Risk assessments, reports & protocols.
Accountable for adopting the ALCOA+ (attributable, legible, contemporaneous, original & accurate) principles and ensuring team working in accordance with registered methods and current Good Manufacturing Practice.
Takes a lead role in approval process. As part of this, is responsible for verifying the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria as per relevant SOP's, customer acceptance criteria, methodology, protocol and product specifications.
Is an analytical expert who provides expertise in laboratory practices and good manufacturing practices (GMP). Uses this knowledge and experience to lead laboratory investigations or project/equipment design.
Responsible for identifying out of specification results. Designs root causing experiments and retest plans, ensuring investigations are completed in a timely manner and that sound scientific rationale has been employed.
Works on long term objectives to deliver specific improvements or embed changes within the laboratory. Takes ownership of project from concept to delivery, providing progress updates throughout lifetime of project.
Responsible for the scientific conduct of project and communication of regulatory issues with senior level team members.

Qualifications

An honours degree in Chemistry or a related discipline is required.
At least 5 years' experience in an analytical laboratory.
Some leadership skills would be advantageous.
Extensive knowledge of Method development and Method validation
Has experience of the analysis of APIs, raw materials and excipients and the associated analytical techniques that may include chromatographic (HPLC, GC, IC), spectroscopic (IR, LC-MS, ICP-OES, Atomic Absorption), physical properties (particle size analysis) and/or pharmacopoeial testing.
Is highly proficient in the use of common laboratory instruments and software packages for the above analytical techniques.
Experienced in problem solving and has expertise in troubleshooting both analytical equipment and methodology.
Competent in the use of corporate IT systems.
Is computer literate and competent in the use of Microsoft packages.
Possesses a thorough understanding of laboratory procedures.
Deep understanding of data integrity and the importance of adopting this guidance when reporting results / everyday work.
Is proficient in the use of numerous laboratory instruments, software packages and other analytical techniques.
Is proficient in problem solving and may have expertise in troubleshooting analytical equipment.
Is competent in application of statistical and mathematical tools and formulae.
Is aware of relevant national / international pharmaceutical regulatory requirements.
Is familiar with equipment / method validation and method transfer procedures.

Thorough understanding of requirements for working in a GMP environment.Additional Information*This is working a 39 hour week on a day shift pattern.*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 61,000 staff across a network of more than 1000 independent companies in over 61 countries and operating more than 900 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.Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!

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