- Reviews and approves documentation associated with QC laboratory equipment, including qualification/validation protocols and reports, periodic reviews, method SOPs, forms, and data tables, to ensure equipment readiness, data integrity, and compliance with applicable regulations and cGMP requirements.
- Reviews QC logbooks.
- Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Valuable Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Mandatory Skills: CSV (Computer System Validation) or Data Integrity