Good Manufacturing Standards (GMP). |Good knowledge of NCF Standards/ UNE-EN ISO 13485 Standard/ Regulation (EU).
Important Pharmaceutical Company.
Guarantee the implementation and effective functioning of the Quality System and the Good Manufacturing Standards (GMP) for medicines for human use, medicines in research, health products and dietary supplements, acting as QP Substitute in accordance with applicable national and/or community regulations.
Coordination of the different areas of the Quality Department
Ensure that GMP and GPD (Good Distribution Practices) guidelines are followed in the supply and distribution chain.
Verify that the technical documentation for production and quality control of the products and the company's Quality System has been prepared and approved by the staff authorized for it.
Ensure that the main manufacturing and testing processes have been validated and taken into account actual production conditions and manufacturing records.
Verify that any deviation or planned change in production or quality control has been authorized by the responsible persons and whether it requires modification of the marketing authorization, which has been previously authorized.
Ensure that each batch has been produced and analyzed according to the procedures of the approved company, the GMP, current legislation and respecting the conditions provided in marketing authorization.
Certify in a document that each manufacturing batch complies with what is indicated in section former. When other manufacturers are involved in the manufacturing of a product, you may base this certification in confirmation of the qualified person of the contract manufacturer, if the Responsibility for this confirmation and the methods and systems used are documented in writing.
Ensures that the quality system is applied to products whose ownership of the marketing authorization corresponds to other laboratories of the Group In these cases, assumes the functions and responsibilities of the Responsible Technician regarding compliance with NCF and BPD.
For medicines and products from third countries, ensure that each batch of imported product is certified by a QP or Responsible Technician of the country exporter that guarantees compliance with the GMP of the EEC/EEA or equivalent and/or any other applicable legislation. However, unless there is an agreement to mutual recognition between the EEC/EEA and the third country, will ensure that samples of each batch in the EEC/EEA prior to batch release certification.
Arrange for the filing of manufacturing documentation for each batch of finished product for a period of time set based on the validity of the product and applicable legislation.
Ensure the correct completion of the Training of the personnel of the Company's technical departments, in collaboration with the departments involved.
Carry out and coordinate internal/external quality audits of the different departments of the company's Quality System, as well as suppliers and audited manufacturers.
Study, evaluate and propose the implementation of corrective and preventive actions aimed at improving processes.
Decide on returned or rejected products and materials.
Manage complaints and product withdrawals from the market.
Review and evaluate security incidents and alerts related to the products that manufactured for the surveillance system and have the means for their communication to the health authorities.
Supervise and approve the documentation related to the development of products (own or those of third parties by contract), ensuring that the adopted systems meet the requirements of the Annex 13 of the GMP: Manufacture of investigational medicinal products, as well as any other applicable regulations.
Preparation and supervision of marketing or commissioning communications of class lla, Ilb and III products, active implantable medical devices and products sanitary devices for in vitro diagnosis included in Annex II and products for auto diagnosis.
Supervision of the documentation required for the registration of the placing on the market of sanitary products (PPSS).
Compliance with current regulations on medical devices.
Supervision of the request for health authorization of clinical research in PPSS.
Supervision of messages aimed at advertising and promoting products sanitary.
Supervision of distribution activities and communication of these to the Communities Autonomous, if applicable.
Approval of documents that concern the management of the system.
Participate in the selection and approve the hiring of personnel in your department and guarantee training.
Coordination with other Departments of the Company.Preparation and monitoring of budgets.
Oportunidades de carrera y desarrollo profesional.
Requisitos mínimos
Bachelor's degree in Pharmacy or Chemistry, with documented experience in Technical Management and Quality Control of medicines for human use, obtained through activity professional developed in one or more authorized companies.
Membership in the Official College of Pharmacists of the Community.
Good knowledge of NCF Standards/ UNE-EN ISO 13485 Standard/ Regulation (EU)2017/745 of the European Parliament and the Council on medical devices and 21 CFR between others.
Training in legislation of quality systems for medicines, products health products, dietary supplements, cosmetics and hygiene products.
