Qualified Person
hace 3 semanas
This role is integral to ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements.
Responsibilities- Making 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 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 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).
- 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.
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