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:

• QC Analyst (Controls and Standards) tasks include;
• Management of standards, controls and critical reagents in the QC laboratory
• Support with inter-site qualification and extension of controls and standards.
• Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
• Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chapters
• Preparation of qualification memo’s in Veeva to support QC testing activities.
• Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
• Ensure compliance to cGMP at all times

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.