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Search Results for Validation Manager
Job Title. Location Salary Actions

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI
EU Not Disclosed

Technical Life Cycle & Engineering Manager

Job title: Technical Life Cycle & Engineering Manager Location: Ballybrit, Galway – Hybrid working model Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. About the role: The role leads a multi-functional team in the development and production of medical devices used for the treatment of stroke. This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight. The Technical Lif...

Location: Galway, Galway City,
Technical Life Cycle & Engineering Manager
Galway Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager
EU Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager
EU Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to all exte...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager
EU Not Disclosed

Validation Manager Career Profile

Validation Manager

The Validation Manager is responsible for the Validation and coordination of operation of machinery and process within the plant. This may be IT systems, various pieces of machinery or Cleaning processes. Salaries start at ca.€32,000 for an entry level position, with an experience Validation Manager being able to command €80,000+. Again, it's an area where many consult on short term contracts, when there is lots of project and construction work in the market.

Key Responsibilities of the Validation Manager

  • To manage all operational validation activities within the client's organisation.
  • To continue to develop and implement a compliant validation strategy for our client.
  • To continue to develop and implement an efficient compliant and cost effective calibration and maintenance programme.
  • To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
  • Be capable of delivering high level reporting to the client's directors.
  • Manage the process for the creation of documentation and requirements to include but not limited to the following:
  • Computer Systems Validation Plans
  • Equipment Validation Plans
  • Cleaning Validation Plans
  • Utility/Facility Validation Plans
  • Components Area Validation Plans
  • Tissue Business Master Validation Plan
  • Despatch Validation Plans
  • Environmental Monitoring Validation Plans
  • Quality Control Validation Plans
  • Scheduling, Planning and review of validation activities.
  • Manage all facets of assigned validation projects while maintaining strong communication with client representative on project status and assistance needed.

Skills & Qualifications:
  • Third level degree in a science/engineering/computer subject as a minimum.
  • At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
  • Good understanding and application of GMP and regulatory requirements.
  • Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
  • Excellent communication / interpersonal skills
  • Previously have managed or supervised a team of experienced engineers in a similar industry.
  • Be a motivator and leader for such a team.
  • Attention to detail.
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