MSD Qualified Person 

Spain, Castile and León, Salamanca 

336614296

Job Description

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

• 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.

• 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.

Current Contingent Workers apply

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