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.In partnership with our client, a prestigious reference company in the pharmaceutical sector, we are recruiting a Quality Assurance Specialist.Responsabilidades chaveGuarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always "audit ready"Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activitiesAct as a catalyst for change and improvement in performance/qualityAssigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQRProvide an example of professionalism and support the induction and training of new colleagues within the areaEfficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assuredManage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reportsTo prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary.Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site auditsPeriodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriateTo close open deviations and propose CAPAs based on the outcome of periodic follow-upsPrepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriateApproves IOPs, process master documentation and product specifications as required and appropriate
