Quality Control/Quality Assurance Specialist

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The Hygeia Group operates a Chemical and Pharmaceutical production and warehouse facility at Oranmore, Co Galway and requires the following additional staff member to join its team.

Job Title

Quality Control/Quality Assurance Specialist

The Quality Control/Quality Assurance Specialist will be responsible for leading and implementing the ISO9001:2015 standard, maintenance of our current GMP Quality System and supporting analysis in the Quality Control Laboratory as required.

The ideal candidate will require at least 3 years experience working in a similiar role, with exprience in the introduction of ISO9001:2015 standard.

A third level degree in chemistry/analytical chemistry or relevant discipline is desirable. The successful candidate will be a self-starter and have strong communication, organisational and interpersonal skills.


  • To report directly to the Quality Manager on all issues relating to Quality Assurance.
  • Implement, lead and maintain ISO 9001:2015 standard.
  • Maintain the current GMP Quality System.
  • Ensure that all Technical Agreements are in place for all contract testing services in cooperation with the Quality Manager.
  • Draft New /Review/Reformat/amend SOPs as required to ensure all SOPs are current.
  • Provide QA support for laboratory method validation and equipment qualification.
  • Manage the preparation, review and issuance of protocols/change controls/storage stability reports process validation reports etc.
  • Assist with the investigation of customer complaints and deviations.
  • Assist in the preparation of Product Quality Reviews PQRs, Corrective Action Procedures (CAPA’s) as required.
  • Ensure all GMP/ISO 9001 documentation is maintained in an audit ready manner
  • Coordination of training/induction training and ensuring that training files are up to date.
  • Provide Quality/Validation support ensuring readiness for upcoming regulatory inspections and assist in the maintenance of systems during routine manufacturing periods.
  • Review and approve documentation provided by external contractors and specifications set in SOPs/Protocols to ensure compliance.
  • Conduct Internal and external audits and close out any findings in a timely manner.
  • Provide support for preparation for HPRA/NSAI audits and the close out of any audit findings in conjunction with the relevant personnel.
  • Quality review of BMRs prior to Qualified Person sign off.
  • Perform analysis of GMP/Non-GMP raw materials, final Products and stability program samples to ensure products meet specification and regulatory compliance.
  • To carry out qualification, maintenance and calibration of laboratory equipment as detailed on the Standard Operating procedures.
  • Drafting /reviewing and ensuring raw material/final product Material Safety Data sheets are compliant.
  • Degree in Chemistry/Analytical Chemistry or relevant discipline.
  • 3+ years experience working in a Quality Assurance role in a GMP/ISO9001 manufacturing facility with experience in Quality Assurance.
  • Lead Auditor training would be an advantage.
  • Proven experience in the management of CAPA and Change Control programmes is desirable.
  • Experience in the introduction of new products/Product transfers/Process Validation is desirable.
  • Strong communication, organisational and interpersonal skills with the ability to influence a team.

Candidates should email a CV and accompanying letter to jobs@hygeia.ie by close of business on Friday 9th February 2018.