QA Validation Specialist

Contract
Dublin, Ireland
Posted 7 months ago

Responsibilities

 

  • Quality oversight of GMP compliance for engineering and validation deliverables related to site and capital projects including requirements definition, specification, engineering design, qualification and change management.
  • Review and approval of validation protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
  • Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
  • Collaboration and participation in projects as a Quality Representative for Validation.
  • Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment & systems.
  • Participation in the evaluation of Change Control and providing support in the review of the associated risk assessments.
  • Supporting process deviation evaluation with regards to validation impact.
  • Ensuring the validation maintenance activities are executed as required including approval in a timely manner of the re-qualification / re-validation activities.
  • Providing subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
  • Maintaining up-to-date knowledge of pharmaceutical legislation and industry best practice.
  • Timely updates of site achievements and challenges and taking a collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive functional group.

 

 

Qualifications & Education

 

  • Bachelor’s Degree
  • Experience in a QA/Validation
  • Experience with Validation in project related activities, including Controlled Area Facilities.
  • Experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
  • Knowledge of/experience with aseptic processing and biologicals.
  • Track record of utilising Risk Based Approaches to Qualification / Validation activities.
  • Track record of identifying, escalating and correcting compliance issues and implementing process improvements.
  • Training Material development and deployment.
  • Detail oriented with ability to multitask

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryQA Validation Specialist

Apply Online

A valid email address is required.