Qualified Person (Porto site production) Full Time

AAA StatementAdvanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

Ensures that every batch of a drug is produced and controlled with respect to the laws and conditions applied to the site which authorize the sale of the pharmaceutical fully compliant to cGMPs regulation, corporate and national guidelines and MA.

• Ensures that every batch of a drug is produced and controlled with respect to the laws and conditions applied to the site which authorize the sale of the pharmaceutical.
• Controls that, in the case of medicinal which come from countries not in the European union, each imported lot, is subject to an semi-quantitative analysis and any other testing necessary to guarantee the quality of the special medicine according to the conditions required for the authorization for the sale of the pharmaceutical.
• Guarantees on appropriate documents that the operations were performed as documented.
• Is responsible for the archiving of the documents for a period of 5 years, and is obligated to show them on request by the health service.
• Immediately communicates all irregularities related to the product to the competent health authorities and to the manager of the company.
• Active collaborate in competent authorities inspections and performs the operations resulting from these inspections.
• Remains vigilant on the general hygiene conditions of the areas in his command.
• Contributes to the definition of production programs, and ensures the realization of quality, in time and with respect for the Good Manufacturing Practice and regulations in force.
• Guarantees that the production operations are documented and is responsible for their archiving and updating.

Minimum requirements

• Pharma Degree
• 5+ years of experience in pharmaceutical industry
• Pharmaceutical Industry Speciality by the Portuguese pharmaceutical Society
• Fluent English