Senior QC Lab Analyst

  • Sligo
  • Permanent
  • JO-1907-64612_1562079255

Summary

Senior QC Lab Analyst

Permanent

RESPONSIBILITIES

· 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.

REQUIREMENTS

· 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.

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