Quality Assurance Specialist
4 settimane fa
Validation Specialist
Vantive, a new company built on our legacy, is a standalone company that will provide best-in-class care to the people we serve. As a Validation Specialist at Baxter Healthcare, you will play a key role in ensuring our processes and equipment meet the highest standards of quality and compliance.
Key Responsibilities:
Drafting equipment qualification and process validation protocols and reports (OQ / PQ) to ensure optimal performance and compliance.
Developing comprehensive cleaning validation protocols and reports to uphold our exceptionally high standards.
Driving tests to support validations, including statistical analysis of data, ensuring accuracy and reliability.
Actively participating in departmental investigations for A3, CAPA, or Non-compliance projects to successfully implement corrective actions and improvements.
Conducting periodic re-evaluations of the validation status of processes and equipment to maintain continuous compliance and quality.
Requirements:
Degree in Engineering, Pharmacy, Biology, or similar disciplines.
Experience in Validation activities or within a Quality Assurance department, preferably in a pharmaceutical company is a plus.
Outstanding interpersonal, organizational, and team-building skills that foster a collaborative and inclusive work environment.
Strong command of English, both written and spoken.
Basic knowledge of statistical concepts and their applications.
Availability to work on weekends when necessary to meet project deadlines.
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