LAR-2403-94
QA RA & PV SPECIALIST
MADRID From MCR International, we are actively seeking a Quality Assurance, Regulatory Affairs, and Pharmacovigilance Specialist & Technical Responsible Deputy in Madrid for a leading pharmaceutical company.
Functions: 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.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 involvedAct as Pharmacovigilance specialist.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.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.Requirements: 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: fluentStrategic thinking, legislation knowledge, decision-making, problem-solving, diligence, accuracy, planning and negotiation skills
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