Job Description
Job DescriptionAn amazing opportunity has arisen for a QA Validation Specialist. This role will be responsible for providing quality support to site qualification activities, including capital projects and re-qualification activities within our state-of-the-art, single-use facility at Dunboyne Biologics.What you will do:Bring energy, knowledge, innovation and influence to carry out the following:Quality oversight of GMP compliance for equipment qualification deliverables related to site and capital projects including requirements definition, specification, engineering design, qualification and change management.Quality oversight of site Shipping Qualification deliverables.Quality oversight of Maintenance & Calibration program.Quality oversight of Pest Control Program.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.Providing support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for all site-based engineering and manufacturing changes associated with validation activities.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.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.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.Compliance with legal, EHS and all company policies and procedures which are applicable to the site.Work ExperienceWhat skills you will need: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).5 years’ experience in a QA/Validation related position within the pharmaceutical Industry.Strong experience with Validation in project related activities, including Controlled Area Facilities.Strong experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.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.Detail oriented with ability to multitask.Ability to interact with multiple stakeholders within the business.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.So, if you are ready to: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.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:10/22/2024*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.Requisition ID:R315759 #J-18808-Ljbffr