Sr Quality Assurance Specialist- FSP Team
2 semanas atrás
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
JOB SUMMARY:
Quality Specialist The goal of this function is to ensure global regulatory and quality practices are implemented in the Affiliate to ensure compliance and safety obligations within Affiliate and local regulations. Functions split between Portugal and Italy. Not specific assignment per country. Pharmacovigilance functions to cover the back- up Local Safety Officer for Portuguese Affiliate. Resident in Portugal. Not required specific location. Fluent in English.Added value if:
Experience as Responsible person in GDP. Experience as QP: Qualified Person (person responsible for the release of the medicinal products on a specific country in EU). Experience as RP: Responsible Person according to European GDP regulations. Experience as Pharmacovigilance. That will be a plus, but it is not mandatory. choice. Knowledge of Spanish/ItalianPrimary Purpose
Local QA contact for the Portuguese Affiliate. The goal of this function is to ensure global regulatory and quality practices are implemented in the Affiliate to ensure compliance and safety obligations within Affiliate and local regulations. Responsibility for the maintenance of the GxP status of the site in accordance with national and international GMP and legal requirements. Ensuring the implementation of Article 83, Directive 2001/83/EC (GDP) in the Affiliate. Verification, management, and vigilance of pharmaceutical products distributed in Portugal according to requirements in place. Taking part of the Release of imported products from Switzerland as non-EU country for the Portuguese market. Verifying the quality oversight of the batches and approving the batch disposition for the Portuguese market. Quality Responsible Pharmacist for the distribution of medicines registered at the Portuguese Authorities (INFARMED)Accountabilities as Quality Specialist Portugal and Italy
Ensuring that quality complaints, deviations are recorded and managed and that quality issues are identified and reported promptly. Support Audits to GxP outsourced activities. Ensuring that a quality management system is implemented and maintained. Management of authorized activities and the accuracy and quality of records. Ensuring that initial and continuous training program are implemented and maintained. Supporting the Quality Lead in self-inspections activities and ensuring that necessary corrective measures are put in place. Keeping appropriate records of any delegated duties. Preparing, reviewing, and approving (as appropriate) the local disposition on the Portuguese/Italian Market for each batch. Verifying the legal conformity for Local suppliers / vendors and customers. Checking and document any returns decision to saleable stock. Participate in the Change Controls committee and approving the actions items in the Electronic Managing System Documentation. Receiving and register the quality complaints, approving the investigation report and send the answer to the customers. Perform the monthly quality Complaints and KPIs and Affiliate cares reconciliation. Review of the Product Quality Review of the Medicines for which the Portuguese/Italian Affiliates is Marketing Authorization Holder. Regular management reviews of the quality management system take place to ensure. that processes are in state of control. the organization is in a state of inspection readiness and preparedness. opportunities for improvement are determined. Pharmacovigilance: Act as back-up of the Local Pharmacovigilance Responsible Person (Local Safety Officer)Accountabilities as Responsible for Portugal
The responsible Person is granted all necessary powers by the Managing Director, which are necessary to fulfill the requirements of the drug Quality legal duties and responsibilities according to EU GDPs.
Coordinating and promptly performing any recall operations for medicinal products. Ensuring that suppliers / vendors are approved. Managing the Customer Qualification and Annual Requalification by Risk Assessment. Give the final disposition of returned, rejected, recalled, or falsified products, in collaboration and consultation with Affiliate Corporate teams where appropriate. First line for Health Authorities exchanges for GDP purposes (audits, communications, recalls, etc.). Approving any subcontracted activities with may impact on GDP. Approving the Quality Agreements related with the 3PL and other Vendors. Managing the Out of Stocks Notifications and Uploading the information in website of INFARMED. Ensure inspection and audits readiness for Portuguese Affiliate. Verifying the quality oversight of the batches at 3PL level and the introduction of the batches for the Portuguese market.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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