Senior Quality Assurance Specialist

RT.Lane; Dublin; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

RT.Lane is seeking a Quality Assurance professional to serve as Qualified Person (QP) under EU GMP. The role ensures the QMS is fit for purpose, approvals of SOPs and GMP documents, and oversight of quality processes.

The successful candidate will have a BSc (Hons) in Science, at least 5 years' QA experience in the healthcare sector, and be prepared to work on a hybrid schedule with three onsite days at City West, Dublin.

Qualifications

• Minimum 5 years of experience in Quality Assurance in healthcare.
• Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
• Experience supporting HPRA inspections and regulatory interactions.

Responsibilities

• Manage QMS, ensure it is fit for purpose and approve SOPs and quality system documents.
• Maintain quality processes and provide QA expertise.
• Support HPRA inspections and prepare written responses to inspections.

Skills

Quality Assurance

GMP Knowledge

Regulatory Compliance

Documentation

Education

BSc (Hons) in Science

Job description

The Quality Assurance, QP has responsibility for the management and maintenance of Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP.

Please note: This is a hybrid role with 3 days onsite required in City West, Dublin.

Role:

• Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
• Maintain Quality processes.
• Participate in managing communications with and represent the company in front of HPRA
• Provide QA expertise
• Support HPRA inspections and prepare written responses to inspections.
• Prepare and approve HPRA variations.
• Provide QA oversight and expertise for New Product Introductions
• Initiate / approve Non-Conformances (NC), CAPA, change controls and complaints.
• Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
• Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
• To approve or reject finished products.
• Ensures that each finished medicinal product batch has been manufactured in accordance with GMP and the MA
• Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
• Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.

Qualifications/ Education:

• BSc (Hons) in Science or equivalent.
• Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
• Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.