Senior Analytical Chemist

  • Galway
  • Complete Laboratory Solutions
Overview: CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis, and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical and pharmaceutical sectors.We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS. This role is located at our client site in Galway. This is a full-time permanent position with CLS.The Role: Senior Analytical Chemist.Location: Client site, Ballybrit, Co. Galway. Reporting to: Regional Service Manager (West).   Duties & ResponsibilitiesGeneration, review and approval of Laboratory Equipment Qualification lifecycle documentation including change controls, risk assessments, protocols, reports etc.Execution of IQ/OQ/PQ protocols for laboratory equipment e.g. HPLC, UPLC, Dissolution Systems, GC etc.Generation of ERES assessments, operational procedures, PM/CAL procedures and schedules.Coordination and scheduling of laboratory equipment vendors to support PM/CAL of laboratory equipment.Troubleshoot instrumentation/test methods and associated Corrective Maintenance.Provision of Equipment Qualification status updates.Escalation of risks and implementation of appropriate mitigations.Perform system administrator duties for stand-alone laboratory equipment e.g. method setup, account creation etc.Perform system periodic reviews for existing laboratory equipment as per defined schedules.Coordinate planning, organization, and implementation of laboratory equipment projects within specified objectives.Lead and coordinate investigations involving deviations from governing procedures and processes.Timely completion of assigned GTrack change controls, CAPAs and tasks.Take oversight of and provide support to all analytical activities.Perform analytical testing in a timely manner for analytical testing, validation and qualification, where appropriate, to ensure project deadlines are achieved for:Campaign support,Material release,Reference standard qualification,Analytical investigations.Ensure all documentation is completed to the required standard, right first-time, in compliance with local procedures and in a timely manner.Ensure all instrumentation used is within calibration and is correctly maintained.Liaise with supervisor to obtain technical support with instrumentation/analytical methodology and laboratory investigations/quality events or related issues.Ensure training is completed before execution of a task.Attend weekly team meetings and participate in a culture, which is committed to high performance, innovation, and continuous improvement and promotes idea sharing.Meet with manager to discuss performance, provide feedback and identify any development opportunities.Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.Ensure a safe work environment for oneself and all employees.Ensure high standards of housekeeping are maintained in the laboratory.Qualifications:Ideally a minimum of a BSC/MSc in analytical chemistry or equivalent.Preferably a minimum of 3 to 5 years’ experience in analytical activities within a pharmaceutical manufacturing environment.Demonstrable expertise in supporting the development of analytical methods, particularly for HPLC and GC.Excellent core competencies such as teamwork, communication skills, and technical writing skills.Strong technical background in chemistry, particularly analytical chemistry.Ability to work to tight timelines.Good Troubleshooting skills.Openness to change, receptiveness to new ideas.Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations. What We Can Offer You:Competitive salary.Unparalleled industry training.Opportunities for professional development and growth across the pharmaceutical, medical device, food, and environment industries.Joining a collaborative and innovative team dedicated to excellence in service delivery. Diversity and inclusion are essential to our mission and achieving our vision at CLS. The diversity we foster is one of our greatest strengths in delivering excellence through our values of honesty, respect, helpfulness, positivity, and integrity without compromise. CLS is an Equal Opportunity Employer.