Places items on hold that does not meet the specification such as incoming material, work in process, and or finished goods. Presents reasons for retention and recommends possible solution to the issue.
Inspects and calibrates equipment used in the lab. Reports non-compliance findings and recommends next step solutions to the QA Manager and facility management on a timely manner. Complies with and enforces GLPs (Good Laboratory Practices), GMP (Good Manufacturing Practices), Safety Practices, etc. Demonstrates and enforces the importance of Good Manufacturing Practices (GMP’s) and monitors diligently. Follows up with necessary corrective actions when not being followed.
Reviews, interprets, verifies, and summarizes data collected from other departments. Reports any deficiencies to QA Manager in a timely manner.
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you will be responsible for:Validation Lifecycle OwnershipLead end-to-end Computer System Validation (CSV) and Computer System Assurance (CSA) activities for GMP-critical systems, including validation planning, protocol development, execution oversight, report approval, and lifecycle management. Ensure systems are validated, maintained, and remain audit-ready throughout their lifecycle.Risk-Based ValidationApply risk-based validation principles to determine appropriate validation strategies, deliverables, and testing approaches based on system GxP classification, business criticality, and regulatory impact.
Lead and facilitate system and functional risk assessments to define validation scope, testing requirements, and compliance controls.Validation Documentation & Compliance EvidenceEnsure validation deliverables, records, evidence packages, system histories, compliance documentation, and deliverable registries are complete, traceable, maintained, and aligned with applicable procedures and regulatory expectations.Knowledge Transfer & Transition SupportEnsure validation documentation, compliance records, and system histories are properly captured and transitioned during system handovers, organizational changes, and service transitions to maintain continuity of the validated state.Qualifications & Experience Bachelor's degree or equivalent in Computer Science, Software Engineering, Information Systems, Life Sciences, Engineering, or a related discipline.
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