LSC has an exciting opportunity for a Quality Systems Specialist to join a leading Global Pharmaceutical company based in Limerick.
Note: This role requires you to be onsite 4 days a week minimum
The Role
This role requires specific experience with electronic quality management systems change control and deviation management.
Duties and Responsibilities
- Ensure that the QMS is managed, developed and implemented appropriate to the activities of the company and all relevant requirements.
- Liaise with all departments to ensure documentation in use complies with customer requirements, regulatory, and external quality standards and is 'audit ready' at all times.
- Liaise with external auditors to schedule audits and monitor the completion of corrective actions in a timely manner to ensure certification is maintained.
- Develop, implement and update QMS policies, procedures and templates and circulate as required. Maintain document control on all documentation.
- Ensure the latest versions of documents are available where needed and that users have the correct access.
- Ensure previous versions of the QMS and external standards are saved correctly and retrievable if required.
- Monitor and maintain the retention times for document storage to ensure that the documentation is retained in a suitable manner to allow retrieval if required.
- Ensure that any changes to system requirements are implemented competently, in a timely manner and that all affected parties are made aware of any changes.
- Provide training and support to employees on document management procedures and QMS requirements.
Preferred Education and Experience:
- Bachelor's degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or a related Life Sciences field
- 5+ years of experience in quality systems within a regulated industry.
- Hands-on experience administering or supporting eQMS modules (Document Control, Training, Change Control, CAPA, Audits, Risk Management).
- Experience leading cross-functional investigations, risk assessments, and continuous improvement projects.
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Siobhan Cummins LSC on 021 4777 329 to discuss in detail or apply directly via this advert.
