Responsibilities
● Designs and drafts validation sampling and testing plan/protocols.
● Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
● Resolve technical issues encountered during study execution.
● Track and expedite the review and sign-off of qualification documentation.
● Support execution of validation activities.
● Interact with individuals from different departments to plan, execute, and complete qualification activities.
● Drive the completion of validation efforts according to deadlines.
● Write / guide the writing of departmental procedures required for validation.
● Assist during internal and 3rd party audits wrt validation requirements.
● Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
● Assist with identifying maintenance and calibration requirements.
● Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
● Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
● Review Validation plans, protocols and SOPs written by other validation team members.
● Manage workload arising from unscheduled events.
● Other duties as assigned by management.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
