Qualified Person

hace 4 semanas


Salamanca, Salamanca, España Mygwork A tiempo completo
Job Title: Qualified Person

This role is an integral part of ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements.

Key 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 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 with other quality units within the company.
Requirements:
  • 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.
  • Advanced knowledge in the processes of product manufacturing, equipment, and facilities.
  • Knowledge in quality control test.
  • Fluency in Spanish.
  • Business Proficiency in English.

Please note that this job posting is effective until 11:59:59 PM on the day before the listed job posting end date. Please ensure you apply to a job posting no later than the day before the job posting end date.


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