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
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