Quality Assurance Specialist

hace 3 semanas

Salamanca, España Merck Sharp & Dohme Corp. A tiempo completo

Job Description
Join our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute to our mission of using leading-edge science to save and improve lives around the world.
Responsibilities Ensure compliance with the Quality Systems in the vaccine manufacturing process.
Ensure compliance with GMP regulations, our company's Quality Manual, and regulatory requirements.
Review batch documentation of products manufactured by our company.
Perform the pre-UD (UD, Usage Decision) process for the release of products manufactured by our company to the market.
Support adherence to the product release plan manufactured by our company.
Manage Quality information and metrics.
Manage Quality Assurance (QA) documentation.
Create and maintain Quality master data in SAP.
Manage specifications.
Review and implement regulatory changes.
Quality member in product complaints.
Preparation and review of PQR (Product Quality Review).
Creation, review, and approval of deviations, CAPAs, and change controls.
Support as QA representative in the introduction or transfer of new products.
Support as QA representative in process validation.
Perform Quality Oversight.
Preparation, review, and approval of risk analysis.
Participation in external and internal audits.
Participation in continuous improvement projects.
Qualifications University education in Health Sciences.
Relevant professional experience in the pharmaceutical sector (at least three years).
Advanced English.
Advanced knowledge of GMP regulations and regulatory requirements.
Demonstrated ability to analyze, solve problems, and communicate effectively (oral/written) in Spanish and English.
Experience in Quality Assurance (QA).
Knowledge of batch documentation review and approval processes by Quality.
Knowledge of product release processes by Quality.
Knowledge of Quality System tools: change controls, deviation management, out-of-specification results, CAPAs, claims.
Data management in SAP.
Demonstrable experience in participation in projects, transfers, and audits.
Preferred Knowledge of manufacturing processes, equipment, and facilities in the pharmaceutical sector, especially in the manufacturing processes of biological and sterile products.
Knowledge of Quality Control (QC) tests.
Experience in risk management, statistical tools, and continuous improvement methodologies.

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