LAR-2404-138QA RA & PV SPECIALISTMADRIDFrom MCR International, we are actively seeking a Quality Assurance, Regulatory Affairs, and Pharmacovigilance Specialist & Technical Responsible Deputy in Madrid for a leading pharmaceutical company.Departament: Quality, RA and PVImmediate superior's positions: Quality, RA and PV managerJob DescriptionAct as Technical Responsible deputy:Support in the maintenance of the Quality Management System. Ensure the correct functioning of the Management System together with the Technical responsible. Verify and ensure that the Company's products comply with the applicable regulations before placing them on the market. Participation in the necessary reviews of placing on the market of the products that Company commercializes.Performing the register of the company products and ensuring that all of them comply with the legislation in force. Planning for new launches and coordinating all of them with the rest of the departments involved. Providing support to any other department: marketing department, supply chain, etc.Act as Pharmacovigilance specialistCore duties of the job:Related to Quality Assurance, supporting in the following tasks:Acting as Responsible Person (Qualified Person) deputy and ensure compliance with GDP regulation.Reviewing the CoA of the batches released by the QP from the manufacturing site and the additional documentation received and ensuring its compliance with the specifications in force.Checking the samples sent from each batch to be released to the marketPreparing release authorizations for the batches to be released in the market.Coordinate/perform audits to outsourced suppliers and manufacturers of the company products and company warehouseDiscuss quality agreementsCommunication with Health Authorities. Handling Health Authorities inspections and external audits related to Quality.Performing self-inspectionsCreating and maintaining the GDP Quality System according to the Good Distribution Practices. Creating and reviewing SOPs.Product quality complaints effectively management and follow-up. Customer complaintsReviewing and registering incidences and No conformities. CAPAsChange controlsQuality metrics, Quality management reviewReviewing the correct transportation of the products from supplier and/or to customerCoordinating product recallsDecide on the final disposition of rejected, recalled or falsified productsApproval of the returns to saleable stockGDP training programsApproving of new customers and service providersManagement and updating of Labofar tool (Communicate supply problems, modifications of the MA holder authorization, apply for authorization for exceptional manufacturing, etc.).Guarantee compliance with the general procedures approved by the Company and the regulations that regulate the pharmaceutical industry.Creating and managing of Company Quality System.Creating and managing of internal procedures and instructions. Implementation in the Company structure.Preparing and providing internal audits of procedures and systems.Related to Regulatory Affairs, supporting in the following tasks:Ensuring that the products comply with the regulations.Preparing dossiers for registration.Negotiation with Health Authorities to obtain Marketing Authorizations.Prepare and submit variations and renewals within the established deadlines.Monitoring and establishment of calendars for variations and revalidation approvals.Stay up-to-date on national and international legislation and guidelines.Respond in a timely manner to the queries requested by the Health Authorities.Preparation, review and approval of packaging materials.Application for import licenses for Company products (annex I, re-control declaration and cover letter), application and file thereof.Maintenance of the physical and electronic files and Regulatory databases.Related to Pharmacovigilance:Acting as Pharmacovigilance specialist. Review the following tasks, that can be outsourced: having an overview of medicinal product safety profiles and any emerging safety concerns; having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products; having awareness of risk minimisation measures; being aware of and having sufficient authority over the content of risk management plans; being involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU; having awareness of post-authorisation safety studies requested by a competent authority including the results of such studies; ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP; ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency; ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product; providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency; providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals); acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections.Minimum qualification requirementsHigher education: Bachelor's Degree in PharmacyA Master of Science or Doctorate will be taken into considerationAt least three years' experience within the Technical Department (RA, QA and PV).English: fluent. Portuguese: desirableCore competences for the job:Strategic thinking, legislation knowledge, decision-making, problem-solving, diligence, accuracy, planning and negotiation skills.Employment typeFULL TIME
