QC Specialist
Industry : Pharmaceutical
Job Description:
The QC Specialist will be responsible for coordinating and/or performing all laboratory activities including but not limited to:
- Mentor and coach QC analysts and Lab Assistants to further develop understanding and competence in GLP and laboratory workflows.
- Coordinate / perform sampling, testing, release and investigation activities associated with materials in accordance with cGMP requirements.
- Coordinate / perform analytical testing including preparation and review of documentation and any investigations for in process and finished combination products in accordance with cGMP requirements.
- Coordinate / perform analytical testing and any investigations with external test laboratories to ensure compliance to cGMP requirements.
- Lead lab support activities (Sample Management, Chemical / Consumables management, Specification / Method management, Equipment Management) to ensure compliance with local procedures and GLP requirements.
- Deliver department Quality Management system deliverables (Deviations, CAPAs, Change control) as required.
Experience and Qualification:
- Must have minimum of Level 8 qualification in scientific discipline.
- 5 – 8 years’ experience in Pharmaceutical QC testing Laboratory is required.
- Experience with testing of devices / combination products / inhalation testing is preferred.
- Experience in mentoring / coaching or leading others is preferred.
Skills:
- Thorough understanding of pharmaceutical QC laboratory operations and GLP.
- Excellent communication skills must be able to comprehend and follow written and verbal
procedures or instructions. - Demonstrated ability to mentor / coach / lead others within a team.
- Must be able to work flexible schedules as required to support lab & production activity.
Location: Tipperary
Duration: Permanent role with 6 months probationary period.