Senior Method Development & Validation Specialist
About the Company
My client is a world leader in food, environment and pharmaceutical product testing. They are also one of the market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing.
About the Position
At their Cork site, they manufacture a number of established commercial products and are successfully engaged in New Product Introductions. The 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 team to ensure the highest quality and productivity standards are met along with the agreed requirements and timelines.
Key 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.
Experience/Requirements
Education / Qualifications
Experience / Skills
- 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.
- Ability to quickly learn new processes.
- Ability to communicate clearly and to form strong working relationships with colleagues.
- Ability to work on own initiative and be capable of developing solutions to problems as part of a team.
Remuneration Package
A competitive package is available including generous salary and benefits.
Contact
Please contact Charlie Bigger on 01 5927861 or email or simply click the apply button.
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