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R&D Quality Assurance Specialist - Alternate Technical Director
* Stay up-to-date on the emergence of new regulations that affect the development of new products.
* Approval protocols for studies and manufacturing guidelines.
* Plan and perform audits based on the criticality of the manufacturing process that make it possible to ensure compliance with the approved guidelines and good manufacturing practices.
* Audit the departments (system audits).
* Audit the final reports of the studies as well as the documentation for the manufacturing lots before their release to verify that this documentation reflects the original data obtained.
* Draft reports of the audits conducted, communicating the results of same to the persons responsible for the inspected procedures. Monitor the actions taken by the persons responsible for correcting deviations detected in the audits.
* Collaborate in the drafting of procedures and approval of technical procedures.
* Collaborate in the GXP training of the staff of the audited departments.
* Assess the impact or GMP compliance of a validation of equipment, instruments, services, facilities and computer systems.
* Participate as a member of the Project Teams or CMC to which he or she is assigned.
* Release of materials in SAPR3.
* Participate in the management of deviations in the quality system and in the improvement of same.
* Act as the Alternate Technical Director/Substitute Qualified Person in the Sant Feliu de Llobregat Plant in the absence of the Technical Director/Qualified Person.
Education
* Quality Standards (NCF, ICH, etc.).
* Courses on Quality Assurance in R&D in pharmaceutical companies.
Skills
Specific knowledge and/or prior experience required:
* To audit NCFs, basic knowledge of the following is required: galenic formulation, galenic industrialisation, instrumental analytical techniques, microbiological techniques.
* Computer systems and networks.
* User of computer programs.
* Statistics.
* Authoring of scientific texts.
* Validation.
Experience
3 - 5 years experience in a similar position.
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