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MSD QA Validation Senior Specialist 
Ireland 
988932852

11.08.2024

Job Description

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

  • Quality oversight of GMP compliance for engineering and validation deliverables related to projects including requirements definition, specification, engineering design, qualification and change management.
  • Quality oversight of Shipping Qualification deliverables.
  • Quality oversight of Maintenance & Calibration Program.
  • Quality oversight of Pest Control Program.
  • Quality oversight of Cleaning Validation Program.
  • Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
  • Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment & systems.
  • Providing support for Permanent Inspection Readiness Program, in preparation for agency inspections, as well as supporting Internal Audit Program as required.
  • Collaboration and participation in projects as a Quality Representative for Validation.
  • Providing support for Annual Product Quality Review and performing quality assessment for all engineering and manufacturing changes associated with validation activities.
  • Ensuring the validation maintenance activities are executed as required including approval in a timely manner of the re-qualification / re-validation and periodic review activities.
  • Participation in multi-site initiatives to ensure harmonization of validation activities across the network as required.
  • Providing subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
  • 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.
  • Maintaining up-to-date knowledge of pharmaceutical legislation and industry best practice.
  • Taking a collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive team.

What skills you will need

  • Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc).
  • Minimum of 8 years’ experience in a QA/Validation related position within the pharmaceutical Industry.
  • Strong experience with Validation in project related activities, including Controlled Area Facilities.
  • Excellent communication skills (written and oral), including the ability to interaction with multiples stakeholders at all levels withing the business.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
  • Experience with Cleaning Validation & Verification.
  • Demonstrated understanding of continuous quality / process improvement tools.
  • Ability to multi-task and handle tasks with competing priorities effectively.
  • Knowledge of/experience with aseptic processing and biologicals.
  • 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 utilising Risk Based Approaches to Qualification / Validation activities.

So, if you are ready to:

Current Contingent Workers apply


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.