Careers

·       Provide validation expertise to develop and coordinate deliverables to validate laboratory equipment and computerized systems for regulated use while ensuring compliance with internal procedures and industry guidelines (e.g. 21-CFR-11, GAMP V, USP-1058, NIST, GCP, GLP and GxP).

·       Development and execution of Laboratory Equipment Validation Protocols.

·       Responsible of Technical Documentation, Risk Assessments, Analytical Instruments Qualification, Computer System Validation, Traceability Matrix, Validation Report, Operational and Administrative SOPs.

·       Execution of related validation protocols and documentation packages for all activities, including: Original format documents, approved document and applicable drawings.

·       Establish system boundaries, scope of work, and commissioning execution plans during Validation Life Cycle.

·       Documenting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), traceability matrices (RTM), deviation forms and validation summary reports (VSR) documents using standard templates.

·       Author and Executing of all Policies, Procedures, Test Methods, Specifications, Validation Documents, forms, and all other documents that pertain to the production, engineering, and maintenance systems.

·       Ensured all the URS are addressed appropriately in the Requirement Traceability Matrix (RTM)

·       Review and approve validation documentation such as Standard Operating Procedures, Validation Protocols (Installation Qualification, Operational Qualification, and Performance Qualification) that are compliant to FDA and Code of Federal Regulations (CFR).

·       Provide task status and escalations in weekly cross functional team project management meetings.

·       Maintain regular project status check-ins with manager and determine task allocation amongst quality team members.

Qualification:

This position requires a minimum of a bachelor’s degree in Pharmacy, Chemical Engineering, or a closely related field.