Quality Assurance Specialist
As a QA Specialist in CSV & Automation, you will ensure compliance in qualification and validation activities for equipment and computerized systems within aseptic facilities, utilities, and GMP manufacturing environments. This role supports large-scale CAPEX projects, such as new drug product facilities, from concept through execution and across all design phases.
Responsibilities
* Develop and implement qualification and validation plans for equipment, infrastructure, and computerized systems in accordance with GMP requirements.
* Review and approve SOPs, commissioning/qualification/validation protocols, reports, and project-related CQV/CSV documentation (e.g., URS, FAT/SAT).
* Provide QA leadership and guidance on qualification and validation topics for ongoing projects, including vendor qualification.
* Serve as the primary point of contact for lifecycle compliance of equipment, infrastructure, and computerized systems, ensuring accurate documentation in global systems (e.g., Kneat, Trackwise, DMS, Unifier).
* Manage quality deviations, changes, and CAPAs/tasks promptly, taking ownership of resolution and escalating when necessary.
Must-Haves
* Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
* Extensive experience in GMP-regulated pharmaceutical environments, ideally within a Quality Unit.
* Proven experience in QA roles focused on CSV and automation for GMP systems related to aseptic fill-finish processes and facilities (e.g., filling equipment, lyophilization, clean utilities, clean room facilities).
Start Date: ASAP
Duration: 12 months
Seniority Level
Associate
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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