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.
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.