GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
We are seeking a QC Analytical Analyst to join our pharma client in Sligo.
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 the company's 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.
Job Type: Full-time onsite #Gertek To start the process click the Continue to Application or Login/Register to apply button below.