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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