Qualified Person
hace 3 semanas
Qualified Person 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.
Responsibilities Making critical decision for bulk, intermediate and finished veterinary medicinal products.
Ensuring that each batch of veterinary medicinal product has been manufactured and controlled in accordance to GMP and other applicable drug legislation.
Reviewing and approving PQR reports related to the products within 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 area of oversight.
Approving, tracking, assessing, completing and extending of CAPAs.
Supporting change management related to the manufacture of the products within 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 area of oversight as well as other continuous improvement opportunities.
Being responsible for Quality Assurance oversight of key quality activities.
Being responsible for contacting with other quality units within the company (e.g.
Regulatory).
Qualifications Required 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 test.
Fluency in Spanish.
Business Proficiency in English.
Preferred Already has attained qualified person certification within Spain.
Experience with managing contract manufacturers or external partners.
Experience in the manufacture of biological and sterile products.
Fluency in English.
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