ABOUT THE JOB:
The position will report to the R&D; Section Manager and will work closely with cross-functional teams within the organization.
Mission:
Lead and coordinate the Stability Studies area within the R&D; Department, ensuring the correct execution, monitoring and documentation of stability studies for pharmaceutical products and associated materials, guaranteeing compliance with GMP regulations, ICH guidelines and internal quality standards.
Main Tasks and Responsibilities:
- Coordinate and supervise the execution of stability studies for pharmaceutical products and associated materials.
- Plan Stability Studies activities according to project timelines and priorities established by the Section Manager and R&D; Management.
- Manage the review and approval of protocols, technical reports and related documentation.
- Ensure compliance with GMP regulations, ICH stability guidelines and internal procedures.
- Supervise the management of stability chambers, sample inventories, study schedules and analytical follow-up activities.
- Evaluate analytical trends,
study results and potential deviations related to product stability.
- Lead investigations related to incidents, deviations, OOS results and CAPA actions within the Stability area.
- Coordinate the technical activities of analysts and laboratory technicians.
- Participate in development projects, analytical validations and analytical method transfers related to stability studies.
- Collaborate closely with Analytical Development, Production, Quality Assurance and Regulatory Affairs departments.
- Prepare technical documentation for audits, regulatory inspections and registration dossiers.
- Propose continuous improvements in processes, organization and operational efficiency within the area.
- Participate in the definition of technical objectives and strategy for the R&D; section.
Requirements:
Academic Background:
- PhD and/or University Degree in Pharmacy, Chemistry, Biotechnology, Biology or related disci