Veterinary Medicinal Product Quality Assurance Specialist
hace 1 mes
Overview
Msd, a renowned pharmaceutical company, is seeking a highly skilled Veterinary Medicinal Product Quality Assurance Specialist to join its team at the Salamanca facility. This pivotal role plays a crucial part in ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory requirements.
Salary: $80,000 - $110,000 per annum
About the Role
The successful candidate will be responsible for making critical decisions for bulk, intermediate, and finished veterinary medicinal products. They will also oversee the manufacture and control of each batch to ensure compliance with GMP and other applicable drug legislation. Additionally, they will review and approve PQR reports, work collaboratively with various departments, and support change management initiatives.
Key Responsibilities
- Making critical decisions for bulk, intermediate, and finished veterinary medicinal products
- Ensuring compliance with GMP regulations and other applicable drug legislation
- Reviewing and approving PQR reports related to products within the area of oversight
- Collaborating with partners in operations, process engineering, and planning to review and evaluate complaints and deviations
- Approving, tracking, assessing, completing, and extending CAPAs
- Supporting change management initiatives related to product manufacturing
- Reviewing and approving validation and qualification documentation
- Creating, reviewing, and approving SOPs, specifications, and test methods
- Supporting site and quality-related projects
Qualifications
To be considered for this role, you will need a minimum BS degree in pharmacy or another relevant field that has attained Qualified Person certification in Spain. You should have a minimum of 5 years' experience in the pharmaceutical industry, with a mix of operations and quality experience. Proven track records of working cross-functionally and demonstrated experience with inspections and regulatory authorities are essential.
Requirements
- Minimum BS degree in pharmacy or another relevant field with Qualified Person certification in Spain
- Minimum 5 years' experience in the pharmaceutical industry
- Proven track record of working cross-functionally
- Demonstrated experience with inspections and regulatory authorities
- Advanced knowledge of GMP and applicable Pharmacopoeias
- Fluency in Spanish and business proficiency in English
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