Quality Specialist
Job details
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
- Lead complaint management and ensure completion of CAPA’s in the required timeframe
- Support site investigations and CAPA management (complaint investigations and Non-conformances)
- Supportissues 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 andcontinual improvement of systemssuch asChange Control & Process Deviation
- Knowledgeable ofISO 9001 & ISO 17025 standards
- Advise, facilitate, and implement systems to ensure continuous improvement of processes & services
- Lead/supportsite compliance toIVDR(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
- Third Level Qualification (Science or Engineering Discipline)
- 3-5 Years plus Previous Experience in a Quality Specialist Role within the Pharmaceutical / Medical Device Sector
- 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
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