Our Client, based North Dublin currently have a Vacancy for a QA Specialist.  This is an exciting opportunity for a QA Specialist that is looking to work in a smaller organisation that is working with manufacturing sites globally across EMEA and Asia. As the QA Specialist, you will be involved in a wide spectrum of work from CMO Quality,  Quality Management, Audits, In-Market Releases, Quality Issues, Documentation and Compliance. The QA Specialist will maintain QMS & will be trained up in Project Management.  Call Orla NOW for full details on 01 8456312

Salary:  to 55K

Benefits:  Performance related Bonus, Pension, Health Cover, Death in Service Benefit

The Role: (QMS)

• Review deviation, OOS and change controls.
• Implement and maintain Quality Technical Agreements with CMOs.
• Ensure all changes are effectively evaluated and implanted to ensure no adverse product impact.
• Oversee market releases of medicinal products.
• Provide QA support where necessary.
• Manage Technical Complaints as appropriate – Investigating and respond to complainants and issue reports.
• Participate any recalls in conjunction with client quality personnel, regulatory bodies, contractors.
• Ensure all CAPAS are effectively implemented as per agreed timeline.
• Write and approve SOP’s and work instructions.
• To ensure all GMP critical SOPs and batch records are approved by Quality and to ensure that all QA GMP related documentation is maintained up-to-date and in compliance with cGMP.
• Prepare quality metric reports.

Primary Requirements: (Project Management)

• To plan and deliver all client projects, to meet technical requirements and to ensure the completeness of project plans, correct allocation & implementation of timelines and project costings. To ensure all personnel are aware of their responsibilities and to monitor progress against key milestones / activity dates and report on progress to the HOQ and Project Team. 

The Candidate: 

• 3rd Level Qualification in Science or equivalent.
• 7 yrs experience in Quality Assurance or Quality Compliance role.
• High-level Computer Literacy and competency – Microsoft Office.
• Vendor Auditing Experience.
• Knowledge of EU Regulations (ICH, EU GMPs, ISO, etc.)
• In-depth understanding of Quality Systems.

Personal Dimensions:

• Must be a self – starter. Achievement oriented with attention to detail and a drive for results.
• Must be able to make effective plans and be able to take steps to carry them out and be able to differentiate and prioritize activities in line with business priorities.
• Must be resilient and flexible to overcome barriers and obstacles to solve problems and identify opportunities.
• Must have good interpersonal skills to communicate effectively with and to support clients and team members.

If this QA Specialist North Dublin Vacancy sounds like you, call us NOW for full details on 01 8456312.

Speak to the experts with the direct LINK to all the best QA Specialist roles in Dublin.

www.linkpersonnel.ie

01 8456312