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Qc analytical expert

Waterford
Elusav Recruitment
Posted: 7 June
Offer description

Elusav Recruitment have an amazing opportunity for a QC Analytical Expert to work with a leading Global Biopharma company in Waterford. This is an incredibly successful biopharmaceutical drug product facility and the role has come about due to capacity expansions, lab upgrades and ongoing QC projects on site. Provide expertise to QC projects and continuous improvements, transfers, validation, qualification activities, deviations and investigations. This is an excellent opportunity to work with a global and progressive leader, with modern labs, with a lot of change and growth in their Waterford site. Extensive progression potential internally. Responsibilities: Providing his/her analytical experts for any project, troubleshooting, investigation on analytical methods and lab technologies. Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans. Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks. Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements. Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities Writing/reviewing and maintaining accurate analytical methods procedures. Informing his/her manager of any quality or HSE event (deviations or OOx) in a timely manner to ensure investigation and impact assessment are performed appropriately. Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately. Performing periodically trend analysis on method performance in order to determine the need to revalidate, optimize or replace the method. Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately. Supporting QC teams during internal, external audits and inspections. Requirements: Higher Level degree in science or equivalent technical discipline. 3years + experience within Pharmaceutical Development, Analytical and/or Manufacturing department. Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements. Ability to analyse complex data and laboratory results to make informed decisions and identify areas for improvement. Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements. Proficiency in identifying issues and implementing effective solutions to resolve quality control problems. Contact: If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on or. Skills: QC GMP Team Player

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