Job Description
This role involves supporting the quality team in maintaining the company's quality management system. The successful candidate will ensure compliance with ISO and GMP requirements, as well as internal procedures.
* Support the Quality team with the maintenance of the Company's QMS.
* Ensure compliance to ISO and GMP requirements and internal procedures.
Accountabilities
* Manage the internal QMS, including raising non-conformances, change controls, CAPAs, quality complaints etc.
* Maintenance of the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures.
* Ensure compliance to Internal Audit schedules, executing internal audits.
* Ensure continual improvement, maintenance of internal KPIs.
* Liaise with fellow team members and ensure awareness to changes to QMS as appropriate.
Key Responsibilities
* Ensure compliance with EU GDP guidelines and other relevant guidelines.
* Experience working under MHRA GDP requirements would be an advantage.
* Ensure safety, quality and traceability of products through entire supply chain.
* Ensure conditions of Wholesale Distribution Authorisation are met.
* Conduct bona fides of suppliers/customers/service providers in timely manner.
* Self-inspections and audits to be carried out as per written audit schedule.
* Act as main point of contact and be legally responsible to HPRA and advise HPRA of any changes.
* Lead regular management review meetings with Senior management teams.
* Coach/Mentor Quality professionals/Deputy RPs.
* Ensure patient safety and product safety at all times.
Requirements
* Bachelor's degree in Life Science subject.
* 5+ years Quality and GDP expertise, including experience named as an RP on a WDA in Ireland.
* Minimum 5 years experience in Quality and GDP.
* 1 year experience named as an RP on a wholesale distribution authorization in Ireland.
* Thorough knowledge of EU GDP requirements.
* Ability to represent clients across different levels of organization.
* Hosting client and competent authority is essential.
* Comprehensive knowledge of ISO standard, GMP and GDP guidelines.
* Experience performing audits would be an advantage.
* Strong interpersonal and communication skills.
* Project manage and multitask workload.
* Excellent attention to detail.
* Maintain client confidentiality and observe discretion at all times.
* Strong work ethic.
* Experience with EQMS implementation is desirable but not a requirement.
* Ability to work with different clients and product portfolios.