QC Analyst

Role Purpose:

• Our client based in Co. Waterford is looking for QC Analyst to join their busy biopharmaceutical facility.
• The function of this position is to provide his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies.

Core Duties and Responsibilities:

• 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

Education & Qualifications Required:

• 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.
• Flexible approach, comfortable with ongoing change and improvement in the organisation
• Ability to drive project deliverables/goals to closure
• Ability to work autonomously while maintaining communication with key stakeholders
• Ability to articulate issues and communicate at all levels, in particular with departmental management and program leads
• Willingness to take ownership for resolution of departmental and/or cross functional issues
• Strong team player with a creative and innovative approach
• Ability to interact effectively in multi-disciplinary teams
• Seeing tasks through to successful completion
• Excellent communicator and attention to detail
• Brings scientific rigour and discipline to approaches

Please note, we do not require agency assistance with this role.