Quality Assurance Validation Specialist reviewing protocols and documentation to ensure regulatory compliance. Collaborating with cross-functional teams in a biopharmaceutical manufacturing environment.
Responsibilities
Review and approve IQ/OQ protocols and reports to ensure they meet internal standards and regulatory requirements
Ensure validation documentation is complete, accurate, and traceable
Review work orders related to maintenance, calibration, or qualification of equipment
Ensure all work is properly documented and compliant with Good Documentation Practices (GDP)
Identify gaps or discrepancies in validation documentation and ensure appropriate corrective actions are taken
Work closely with validation engineers and cross-functional teams in quality control, manufacturing, and maintenance
Participate in audits and inspections, providing validation documentation as required
Requirements
Bachelor’s degree in science minimum (preferably in microbiology, chemistry, or biology)
At least 2–3 years of quality assurance experience within the biopharmaceutical or pharmaceutical manufacturing industry
Specialist-level expertise with advanced knowledge of quality systems
Good understanding of validation principles (IQ/OQ/PQ)
Proficient computer skills with MS Office and Adobe Acrobat
Strong organizational skills, attention to detail, and ability to meet deadlines
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