- Solid knowledge in all quality systems concerning the aseptic manufacture of sterile, liquid dosage form products.
- Solid knowledge in secondary packaging operations with a focus on serialization & cold chain requirements.
- Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.
- Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CAPA management, change control, and batch documentation review.
- Support regulatory submissions and inspection readiness activities.
- Build relationships and influence external partners to continuously enhance quality culture and business excellence.
- Apply applicable GMP regulations international requirements to all aspects of the position.
- Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline.
- Minimum of 8 years work experience in a regulated pharmaceutical environment.
- Experience in pharmaceutical aseptic manufacturing operations or quality assurance.
- Detailed knowledge of cGMPs related to pharmaceutical production.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and make critical decisions with limited information required.
- Advanced degrees are a plus and may reduce the experience required.
- Experience in vaccines production.
- Proficient in applying process excellence tools and methodologies.
- Experience working with external manufacturers.
- Spanish speaking and located in BCN.