Job Description
Join our team at our Salamanca facility as a Qualified Person.
This role is integral to ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements.
As a Qualified Person, you will make critical decisions for bulk, intermediate, and finished veterinary medicinal products.
You will also have the opportunity to work cross-functionally with other departments and functions to successfully deliver high impact projects and objectives for our organization.
ResponsibilitiesMaking critical decisions for bulk, intermediate, and finished veterinary medicinal products.Ensuring that each batch of veterinary medicinal product has been manufactured and controlled in accordance with GMP and other applicable drug legislation.Reviewing and approving PQR reports related to the products within the area of oversight.Working in close collaboration with partners in operations, process engineering, and planning to review and evaluate complaints and deviations related to the products within the area of oversight.Approving, tracking, assessing, completing, and extending CAPAs.Supporting change management related to the manufacture of the products within the area of oversight.Reviewing and approving validation and qualification documentation.Creating, reviewing, and approving SOPs, specifications, and test methods, manufacturing, and packaging protocols.Supporting the execution of site and quality-related projects related to the product in the area of oversight as well as other continuous improvement opportunities.Being responsible for Quality Assurance oversight of key quality activities.Being responsible for contacting other quality units within the company (e.g., Regulatory).QualificationsRequired: Minimum BS degree in pharmacy, or other degree that has attained qualified person certification within Spain.Minimum 5 years' experience in the pharmaceutical industry.Majority of experience supporting pharmaceutical manufacturing operations, with a mix of operations and quality experience.Proven track record of working cross-functionally with other departments and functions to successfully deliver high impact projects and objectives for their organization.Demonstrated experience with inspections and regulatory authorities.Advanced knowledge in GMP and applicable Pharmacopoeias.Advanced knowledge of Quality System tools (change controls, deviations management, out of specifications, equipment qualification, process validation, product validation, elaboration of risk analysis, annual product reviews, claims, audits, self-inspections, etc.
).Advanced knowledge in the processes of product manufacturing, equipment, and facilities.Knowledge in quality control tests.Fluency in Spanish.Business Proficiency in English.Preferred: Already has attained qualified person certification within Spain.Experience with managing contract manufacturers or external partners.
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