Quality Specialist

My client requires a Quality Specialist to join their Quality Team for a 12 Month Fixed Term Contract.

Based in Galway City this leading Life Science & Pharmaceutical Firm has plans to expand its facilities in 2024 and will be looking to take on board an established Quality Specialist who has 3-5 Years’ experience already working in a regulated environment (Pharma, Medical Device, Biotechnology).

Offering a competitive package (€) with the possibility of a contract extension, if you are looking for a new challenge – APPLY TODAY

 

Quality Assurance Specialist / QA / Quality Officer / Quality / QMS / HPRA / INAB / Pharmaceutical / Biologics / Life Science / Galway / Ireland

 

Job Title: Quality Specialist

Location: Galway

Reporting: QA Manager

Package:

• 12 Month Fixed Term Contract
• €45k – €50k+ Basic (Dependent on Experience & Open to Negotiation)
• Income Protection Insurance
• Paid Annual Leave
• Parking

 

Role:

 

Support the Quality Management Systems and maintenance of Good Manufacturing Practice (GMP), Good Documentation Practice (GDocP), Regulatory compliance and ISO certifications for the business.

 

Duties and Responsibilities:

• Lead complaint management and ensure completion of CAPA’s in the required timeframe
• Support site investigations and CAPA management (complaint investigations and Non-conformances)
• Support issues management (Recalls, Complaints, and Vigilance)
• Assist and develop in house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files etc.
• Support completion of audit schedule
• Coordination of KPIs for issues, audits and CAPAs
• Support quality risk management under ISO 14971
• Delivery of relevant training requirements such as Quality, GDocP, and GMP
• Support management and continual improvement of systems such as Change Control & Process Deviation
• Knowledgeable of ISO 9001 & ISO 17025 standards
• Advise, facilitate, and implement systems to ensure continuous improvement of processes & services
• Lead/support site compliance to IVDR (EU) 2017/746

• Support the maintenance of the Environmental, Health & Safety System management
• Maintain an in-depth knowledge of the business and products, the customers, suppliers, and the market dynamics
• Support of projects, sharing knowledge and providing expertise
• Report incidents, field safety notices and pharmacovigilance issues to head office quality department when required
• Support the preparation and submission of data for monthly, quarterly, and annual reports (KPIs), and assist with management review preparation
• Assist with the preparation and participate in/lead Internal and External Audits (e.g SGS, HPRA, INAB & Customer Audits)

• Manage and maintain good professional working relationships both internally and externally to the business

 

Experience:

 

• Third Level Qualification (Science or Engineering Discipline)
• 3-5 Years plus Previous Experience in a Quality Specialist Role within the Pharmaceutical / Medical Device Sector

 

Personal Characteristics:

 

• Relationship Building: Establishing excellent working relationships with the Business Unit Planners. Hands on approach and giving clear and concise instruction when required
• Communication: Excellent communication and presentations skills, both written and oral – ability to present forecasting, capacity, and other relevant planning data in a clear and concise manner to the Business Unit Planners and where required, to management
• Planning & Organising: Able to plan activities and tasks
• Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
• Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
• Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles

If you would like to be considered for this opportunity why not contact me directly on my mobile 00353 (0) 87 25 35 247; Just ask for Patrick.

Alternatively follow the links below and send me your CV.

 

Key Words: Quality Assurance Specialist / QA / Quality Officer / Quality / QMS / HPRA / INAB / Pharmaceutical / Biologics / Life Science / Galway / Ireland

 

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