Vaccine Quality Assurance Expert

hace 1 mes


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

**Job Overview:**

Merck Sharp & Dohme Corp. is committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.

**Salary:** $85,000 - $110,000 per year

**Job Description:**

As a Vaccine Quality Assurance Specialist at Merck Sharp & Dohme Corp., you will play a crucial role in ensuring the quality of our vaccine manufacturing process.

**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) 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.

**Benefits:**

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for career growth and development.



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