PE Global is currently recruiting for a Chemistry Team Group Lead for a leading multi-national Pharma client based in Cork.
The role will involve leading the PSS team to develop & optimise analytical methods along with method validation and transfer, according to regulatory guidelines.
Role:
- 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.
- Full time permanent position, day role no shift work.
- 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.
Requirements:
- An honours degree in Chemistry or a related discipline is required.
- Experience / Skills
- At least 5 years’ experience in an analytical laboratory.
- Excellent leadership skills and at least 2-3 years previous supervisory experience.
- 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up-to-date CV to niamh.mcdonald@peglobal.net.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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