Method Development & Validation Specialist
Employment type:
Full-time
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 and has over 15 years of service in Ireland and over 22 years globally.
For more information about Eurofins PSS, please visit our website.
We currently have opportunities to join our innovative 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?
Developmental opportunities and career progression
Opportunity to work with a world-leading pharmaceutical and biotechnology company
Accessible location
Private Medical Insurance
Income protection and life assurance
Annual discretionary bonus
Free parking onsite
Full use of canteen facilities on the client site
Additional annual leave days with continued service
Opportunity to work on products helping to save lives across the world
Primary purpose
: The role will develop and optimise analytical methods along with method validation and transfer according to regulatory guidelines.
The role involves participating in a Professional Scientific Services (PSS) team to ensure the highest quality and productivity standards are met along with client requirements and timelines.
Job Responsibilities
Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data.
Support innovative development of new analytical methods and improvement/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 development, validation/qualification and transfer of methods.
Communicate regularly with clients, providing updates on project progress, addressing technical queries and delivering client project requirements to defined timelines.
Ensure project delivery within the required timeframe and that the site's technical, quality and safety metrics are achieved.
Provide suitable training to adopt new practices where required.
Review and approve standard operating procedures (SOPs), laboratory methods, COSHH assessments, laboratory investigational reports, validation protocols, risk assessments, and related reports & protocols.
Adopt ALCOA+ principles and ensure team working in accordance with registered methods and current GMP.
Lead in the approval process; verify the quality and accuracy of analytical results and determine if material meets pre-defined acceptance criteria per SOPs, customer criteria, methodology, protocol and product specifications.
Act as an analytical expert, providing expertise in laboratory practices and GMP; lead laboratory investigations or project/equipment design as needed.
Identify out-of-specification results, design root-cause experiments and retest plans, and complete investigations timely with sound scientific rationale.
Work on long-term objectives to deliver improvements or embed changes within the laboratory; own projects from concept to delivery with regular progress updates.
Responsible for the scientific conduct of the project and communication of regulatory issues with senior 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.
Experience in analysis of APIs, raw materials and excipients with techniques such as chromatographic (HPLC, GC, IC), spectroscopic (IR, LC-MS, ICP-OES, Atomic Absorption), physical properties (particle size analysis) and/or pharmacopoeial testing.
Proficient in the use of common laboratory instruments and software packages for the above techniques.
Experience in problem solving and troubleshooting analytical equipment and methodologies.
Competent in the use of corporate IT systems and Microsoft packages.
Thorough understanding of laboratory procedures and data integrity importance in reporting results.
Proficient in various laboratory instruments, software packages and analytical techniques, with problem solving and potential troubleshooting expertise.
Competent in applying statistical and mathematical tools and formulae.
Aware of relevant national/international pharmaceutical regulatory requirements.
Familiar with equipment/method validation and method transfer procedures.
Thorough understanding of requirements for working in a GMP environment.
*This is a 39-hour week on a day shift pattern.
*Benefits include pension contribution, medical insurance, health insurance and bonus.
*Eurofins Management and Team support on client site.
*Opportunity to work with fantastic people and be part of a great team.
Eurofins Scientific
is an international life sciences company providing analytical testing services to clients across multiple industries.
Eurofins aims to make life and the environment safer, healthier and more sustainable.
Eurofins operates over 900 laboratories in 61 countries and offers a portfolio of analytical methods to evaluate safety, identity, composition, authenticity, origin, traceability and purity of substances and products.
Eurofins PSS Insourcing Solutions is a global insourcing solution placing skilled teams at client sites to manage operations with consistent service and cGMP compliance.
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