Senior QA Tech Specialist - QMS

Site Name: Guayama JV Posted Date: Oct 6 2021 Are you looking for a career where you can lead the site compliance to contribute to the customer's health? In the Quality System Compliance role, you will act as the site Point of Contact (POC) between the Network Team and site/function all leadership teams for effective communication, assessment and implementation of existing, new or revised Quality Management System (QMS), Compendia changes, Regulatory product declarations, and Material qualification with market's regulations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: QMS Champion Ensures deployment of the QMS to manufacture, test, and supply our products. Participates in the QS Network Meetings, acts as the QMS Champion across all Site operations, providing support/training/coaching for QMS Process Owners, as well as a reviewer of all implemented actions. Ensures that all QMS documents are assessed regarding QMS applicability/deployment, and to manage the Site QMS implementation process. Notify operational managers, technical experts and other impacted target groups of new or revised QMS documents to properly QMS gap analysis ensuring the Site is compliant or action plan is defined. Also serve as a primary review of gap analysis. Escalates significant QMS risks and issues related to QMS implementation, provide regular reports on progress against gap closure action plans. Report QMS implementation status as needed in the different forums such as Quality Council, Network meeting, etc. Compendia Changes Participates in the Compendia network meetings. Ensures that compendia changes are assessed regarding compendia applicability/deployment and manage the implementation process. Notifies the technical experts and other impacted target groups of new or revised compendia documents to properly gap analysis ensuring the Site is compliant or action plan is defined such as Change Control, procedures revision, etc. Escalates significant risks and issues related to compendia changes implementation, provide regular reports on progress against gap closure action plans. Report QMS implementation status as needed in the different forums such as Quality Council, Network meeting, etc. Regulatory Acts as the contact to provide regulatory product declarations supporting product submissions, registration or license renewals, and Regulatory Product Periodic Reviews. Participates as site representative with CMC Team to define timeline and strategies to provide the requested information aligned to the Regulatory agency's due dates. Notifies/follow up the technical experts and other impacted target groups to ensure the site provide the applicable documentation. Escalates significant risks and issues related to product submissions, registration or renewals compendia changes implementation, provide regular reports on progress against gap closure action plans. Material Qualification program Supports the Material Qualification program to ensure the Raw Materials and Packaging are in compliance with regulations such as BSE/TSE, Residual Solvents, GMO, Allergens, Elemental Impurities, Nitrosamine, etc. Escalates significant risks and issues related to current or alternate materials with potential of impact in our product. Other responsibilities Makes decisions regarding the accuracy, completeness, and compliance with Policies and procedures. Represents the Quality Assurance Compliance function in internal meetings, with 2nd and 3rd party contract firms. Support the Quality System team, as needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in science is required (Chemistry, Engineering, Pharmacy preferred). 3+ years of relevant pharmaceutical industry experience. 3+ years of regulations experience Knowledge of technical, Quality Control, manufacturing and packaging process regulations. Preferred Qualifications: If you have the following characteristics, it would be a plus: Sense of urgency to handle critical projects. Excellent verbal and written communication skills. Strong interpersonal and negotiation skills; ability to influence diverse matrix of stakeholders and peers across the organization. Problem- solving skills; with a disposition for continuous improvement. Ability to collaborate in cross-functional teams. Ability to adapt, anticipate issues and escalate them to upper management. Good judgment to make independent decisions. *LI-GSK Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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