MSD QA Validation Associate Specialist 

Ireland 

624345811

Job Description

An amazing opportunity has arisen for the role of QA Validation Associate Specialist withinour state-of-the-art single use biologics facility in Dunboyne, County Meath, Ireland.

Bring energy, knowledge, innovation and influence 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.

• Providing support for Permanent Inspection Readiness Program, in preparation for agency inspections, as well as supporting Internal Audit Program as required.

• Providing support for Annual Product Quality Review and performing quality assessment for all engineering and manufacturing changes associated with validation activities.

• 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.

In order to excel in this role, you will more than likely have:

• Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc).

• Minimum of 3 years’ experience in a QA/Validation related position within the pharmaceutical Industry.

• 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.

• Excellent communication skills (written and oral).

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures.

• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.

• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.

• Ability to interact with multiple stakeholders within the business.

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.