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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Specialist


Reference:RK26586 Location: Carlow
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Quality Assurance Specialist
Days & hybrid
RK26586
Contract 11 months
Carlow




We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Key Responsibilities:

  • Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original,and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
  • Attend and successfully complete applicable cGMP training.
  • Responds to Operational and business area’s, drives compliance with cGMP and corporate regulations.
  • Drives cGMP/GDP compliance in the performance of day-to-day business activities.
  • Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products and aids resolution
  • Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where required
  • Provides expertise & quality support for the introduction of new products onto site in relation to product release where required
  • Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
  • Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
  • Review and approval of all manufacturing batch/ material documentation including electronic batch records, real time reports, master data using the site systems where required.
  • Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.



Education and Experience:
  • Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
  • 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
  • Demonstrated experience working within Quality Systems and Compliance functions, including management of quality records, deviations, CAPAs, change controls, investigations, Complaints and document management systems.
  • Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
  • Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.


If interested in this posting, please feel free to contact Rachel Kent at Life Science Recruitment for further information.