MSD QA Validation Senior Specialist 

Ireland 

988932852

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.