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Qualified Person
hace 5 días
**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.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
10/8/2024
**Job Posting End Date**:10/08/2024
**Requisition ID**:R314753
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