Commissioning, Qualification and Validation (CQV) Quality Assurance Specialist

Website Kyron Innovative Technologies

Our client is currently constructing a state of the art pharmaceutical facility in Dunboyne, Co. Meath which will provide Drug Substance manufacturing capabilities for Clinical Supply, Registration & Commercial Launch. 

Job Title: Commissioning, Qualification and Validation (CQV) Quality Assurance Specialist

Your Role:  Your role will be to advise on quality related issues, in order to ensure optimal quality of released products and processes. 

You will understand the quality requirements for the introduction of materials to site, and will have the capability to communicate requirements to suppliers and will use good documentation practices and be capable of implementing these at a local level.

A person who requires minimal work direction is needed for this role, who is highly skilled and knowledgeable to the position.

Job Description:

Provide Quality oversight on design and qualification activities as part of the design, construction, qualification and start-up of the new manufacturing facility.

Location: Dunboyne, Co. Meath

EU Work Permit essential

Salary:  Negotiable

Job Responsibilities:  

  • Supporting qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
  • Quality SME for the execution and reporting phases of the qualification and validation activities associated with the facility.
  • Review and approve all documentation where required specific to Qualification/Validation activities.
  • Ensure any investigations/deviations associated with validation activities are thoroughly investigated and closed in a timely manner
  • Oversee the Project Change Management Process and approve Project Change Requests where required.

Qualifications/Experience required:

  • Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
  • Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
  • Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
  • Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.

About Kyron Innovative Technologies

Our clients in the Semiconductor, Pharmaceutical and Data Centre sectors rely on us to ensure that their new or existing facilities operate at peak performance. Our expert staff of engineers assist in confirming whether critical infrastructure systems are designed and subsequently installed properly and maintained successfully over time. Our commissioning team works with the design, construction and quality team throughout the Full Life Cycle Commissioning process


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