Job Title:
Senior Quality Assurance Specialist
Description:
This is a 12-month fixed-term contract with potential for permanency. The Senior Quality Assurance Specialist will play a key role in maintaining the Company's Quality Management System (QMS).
Key Accountabilities/Responsibilities:
* Support the Quality team in ensuring compliance to ISO and Good Manufacturing Practice (GMP) requirements;
* Manage the internal QMS, including raising non-conformances, change controls, Corrective Action Preventative Action (CAPA), quality complaints etc.
* Maintain the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;
* Ensure compliance to Internal Audit schedules, execute internal audits;
* Liaise with fellow team members and ensure awareness to changes to QMS as appropriate.
Specific to Role of Responsible Person:
* Ensure compliance with the requirements of EU Good Distribution Practice (GDP) guidelines and other relevant guidelines including Health Products Regulatory Authority (HPRA) local guidelines;
* Experience working under MHRA GDP requirements would be an advantage;
* Ensure the safety, quality and traceability of products are maintained through the entire supply chain;
* Act as the main point of contact and be legally responsible to the HPRA and advise HPRA of any changes in a timely manner;
* Lead regular management review meetings with Senior management teams;
* Coaching/Mentoring Quality professionals/Deputy RPs;
* Ensure patient safety and product safety at all times.
The ideal candidate will have excellent communication skills, attention to detail and strong analytical abilities. They will also possess a thorough understanding of Quality Management Systems and experience in a similar role.
A competitive salary package and opportunities for career growth and development will be offered to the successful candidate.