Confira as oportunidades no Brasil
Farmacêutico (a) responsável
Cargo: Responsável Farmacêutico Brasil
Requisition ID 40223 - Posted - Rio de Janeiro - Brazil - Regulatory Affairs - Permanent position - Professionals
A highly motivated and experienced professional to join and lead the Regulatory and GDP team in Brazil. The Responsible Pharmacist will be responsible to maintain all Marketing Authorizations valid in Brazil to register new Octapharma products. This position will also assume three main roles, representing the LDSO, the GDP Officer and the Qualified Person for Octapharma Brazil.
Maintain all Marketing Authorizations of Octapharma at ANVISA, aligned with Corporate instructions.
Prepare, submit and approve new registrations.
Update of Plasma Master File on Marketing Authorizations.
Fulfillment of the regulatory requirements.
Licenses, national and international certificates: licensing, initial certification, renewals, national inspection of Octapharma Brazil.
Support international inspections of Octapharma manufacturing sites by ANVISA.
Artwork of packaging materials: update, review and approval following Brazilian legislation and Octapharma policy.
Handling of technical subjects related to all regulation bodies (CRF/ANVISA/CVSRJ) and MoH.
Monitoring the Health Regulations: working with professional organizations, anticipating trends and promotional material.
Technical support on Octapharma products and competitors.
Manitenance of updated and revised technical documentation for each product.
Maintain the Quality Policy in the Brazilian Subsidiary: SOPs, instructions, organizational charts, training.
Self-inspection: critical points to be checked at intervals, ratification of the efficiency of quality systems, definition of Corrective and Preventative Actions to be taken once failures have been diagnosed.
Act as LDSO according Corporate Octapharma Policy defined by CDSU.
Receipt and handling of all adverse events according to Brazilian legislation.
Assure monthly research of ADR related with Octapharma products on scientific publications in Portuguese language within Brazilian territory.
Enforce GDP regulation in Brazil aligning Brazilian legislation and corporate procedures.
Customer Service: Assistance to all customer complaints and inquiries. Support distributors on quality and serice complaints.
Complaints and Recalls: Handling of all quality deviations.
Supervise temperature transport chain of importation process: Evaluation of all shipments t temperature deviations, preparation of temperature reports, preparation of release reports of batches.
Distributors Rating: Audits, support and documentation for release on imported goods.
Supporting the department in various administrative tasks
The ideal candidate
You have a pharmaceutical degree and 1 to 3 years work experience in a similar function. Your English written and oral communication skills are excellent. You have a good grasp of pharmaceutical and biotechnological concepts, as well as solid knowledge of Regulatory Affairs of biological drugs. You have a good command of eCTD, with experience in GMP and GDP regulation. You are high motivated and analytical, working independantly and methological. You are a team player and self-starter who operates effectively in a highly dynamic environment where priorities can change rapidly.
Develop and grow a professional career in an exciting, challenging and international environment.
You will have a high level of influence where you can make a difference and leave your footprint.
Be rewarded with an attractive salary and benefits package.
Work with skilled and fun colleagues.
How to apply
Please apply online in English describing your interest, expected salary and enclosing your CV, references and/or recommendation letters.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 9,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 160 plasma donation centres across Europe and the USA.