Quality Specialist

2 weeks ago

Dublin, Dublin City, Ireland Independent Search Solutions Full time

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)
  • 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

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 ; 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

Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place you can be assured that your details will not be shown to any of ISS Ltd's clients without your consent.

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