Our client, a leader in the Pharmaceutical Industry, is seeking a QC Analytical Analyst to join their Sligo Team on an initial 6-month contract.
RESPONSIBILITIES
- Ensuring Analytical Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
- Understanding 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 using ‘Zero, Believe it, Achieve it’
- 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 management to rectify.
- Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through the quality system.
- Ensuring 5S excellence is maintained across the Laboratory.
- Instilling a quality culture of Zero, Believe it, Achieve it amongst the laboratory team
- Ensuring that all laboratory test equipment is utilised and maintained correctly.
- Maintaining up-to-date, complete and precise records of all tests performed.
- Investigates Documentation related events in production that have quality or compliance impact.
- Leads or participates IIA, RCI sessions.
- Documents investigation outcomes.
- Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
- Comply with AbbVie policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.
REQUIREMENTS
- Bachelor’s Degree or equivalent, preferably in a Science or related field
- Experience Level = 1+ Years
- Experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines
- Proven track record in an analytical role.
- Proficient in using analytical equipment in a QC lab as well as troubleshooting.
- Knowledgeable in instrumentation such as UHPLC, SoloVPE, TOC, and Identification techniques.
- Experience in industry is essential.
For a confidential discussion and more information on the role, please contact Emma Daly
emma.daly@collinsmcnicholas.ie
0861041202
