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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Quality Control Specialist


Reference:AS22952 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

Quality Control Specialist

AS22952

Contract – 12 months

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.

Reporting into the Quality Control Manager, the Quality Control Specialist will be responsible for supporting all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.

They are an expanding site and this is an excellent opportunity.

Duties:

  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
  • Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings.
  • Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification.
  • Participate and support Internal/External Investigations.
  • Coordinate the creation/ update to Quality standards for raw materials and components at Carlow.
  • Complete impact assessments for change controls related to Carlow processes.
  • Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Coordination, ownership, and author as required for Annual Product Review.
  • Participate in Quality Risk Management.
Experience, knowledge and skills:
  • 2-4 years of experience in a cGMP laboratory environments.
  • Bachelor’s degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience.
  • Knowledge of or previous experience in New Material Introduction process.
  • Method validation and method transfer experience would be advantage.
If interested in this posting please feel free to contact Avishek Singh on +353 (0)87 282 7991 or [email protected] for further information.