· Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
· Understand Regulations and business processes required to maintain Laboratory Data Integrity.
· Ensuring timely completion of all laboratory analysis assigned to shift.
· Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
· Improving the overall efficiency and velocity within the assigned team.
· Identifying and implementing improvements in analytical practices.
· Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
· Identifying weaknesses in laboratory performance and working with the laboratory Supervisors to rectify.
· Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through Soltraqs.
· Acting as designee for the Laboratory Supervisor as assigned.
· Ensuring 6S excellence is maintained across the Laboratory.
· Instilling a quality culture among the QC laboratory team
· Ensuring that all laboratory test equipment is utilised and maintained correctly.
· Executing and / or supporting projects through the Lab Management team.
· Maintaining up-to-date, complete and precise records of all tests performed.
· Acting as the primary point of contact for any analytical issues which arise.
· Developing expertise and understanding of current and future analytical techniques.
· Developing and changing of in-house laboratory procedures as appropriate.
· Carrying out verification of testing records & generation of Final CoA as necessary.
· Positively contribute to departmental programs such as CI, BEx and RFT.
· Supports the transfer of new products to the QC Laboratory.
· 3rd level qualification in a relevant Science discipline
· Minimum 2 years analytical experience in the pharmaceutical industry.
· Proven track record in an analytical role. Must be expert in HPLC, GC,LCMS, GCMS, Automatic titration, Identification techniques.
· Strong knowledge on regulatory requirements.
· Proficient in using analytical equipment in the QC lab.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists