QA Validation Senior Specialist

<p>Job Description</p><p></p><p><span>An exciting opportunity has arisen for a QA Validation Senior Specialist for our manufacuting hub at our Dunboyne site.</span></p><p></p><p><b><span>What you will do:</span></b></p><p><span>Bring energy, knowledge, innovation and leadership to carry out the following:</span></p><ul><li>Quality oversight of GMP compliance for engineering and validation deliverables related to projects including requirements definition, specification, engineering design, qualification and change management.</li></ul><ul><li>Quality oversight of Shipping Qualification deliverables.</li></ul><ul><li>Quality oversight of Maintenance &amp; Calibration Program.</li></ul><ul><li>Quality oversight of Pest Control Program.</li></ul><ul><li>Quality oversight of Cleaning Validation Program.</li></ul><ul><li>Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.</li></ul><ul><li>Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment &amp; systems.</li></ul><ul><li>Providing support for Permanent Inspection Readiness Program, in preparation for agency inspections, as well as supporting Internal Audit Program as required.</li></ul><ul><li>Collaboration and participation in projects as a Quality Representative for Validation.</li></ul><ul><li>Providing support for Annual Product Quality Review and performing quality assessment for all engineering and manufacturing changes associated with validation activities.</li></ul><ul><li>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.</li></ul><ul><li>Participation in multi-site initiatives to ensure harmonization of validation activities across the network as required.</li></ul><ul><li>Providing subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.</li></ul><ul><li>Participation in the evaluation of Change Control and providing support in the review of the associated risk assessments.</li></ul><ul><li>Supporting process deviation evaluation with regards to validation impact.</li></ul><ul><li>Maintaining up-to-date knowledge of pharmaceutical legislation and industry best practice.</li></ul><ul><li>Taking a collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive team.</li></ul><p></p><p><b><span>What skills you will need</span></b></p><ul><li>Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc). </li></ul><ul><li>Minimum of 8 years’ experience in a QA/Validation related position within the pharmaceutical Industry.</li></ul><ul><li>Strong experience with Validation in project related activities, including Controlled Area Facilities.</li></ul><ul><li>Excellent communication skills (written and oral), including the ability to interaction with multiples stakeholders at all levels withing the business.</li></ul><ul><li>Strong experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.</li></ul><ul><li>Experience with Cleaning Validation &amp; Verification.</li></ul><ul><li>Demonstrated understanding of continuous quality / process improvement tools.</li></ul><ul><li>Ability to multi-task and handle tasks with competing priorities effectively.</li></ul><ul><li>Knowledge of/experience with aseptic processing and biologicals.</li></ul><ul><li>Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.</li></ul><ul><li>Track record of utilising Risk Based Approaches to Qualification / Validation activities.</li></ul><p></p><p>As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.</p><p></p><p>So, if you are ready to:</p><p></p><p>Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.</p><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/142