Our client a leader in the Pharmaceutical Industry, is seeking a QC Analytical Anyalyst to Join their Sligo Team on an inital 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 preferential, 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
