Quality System Support
* Support implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 9001 and/or ISO 13485.
* Assist in managing controlled documents, including SOPs, policies, forms, and validation records.
* Participate in internal audits and help prepare for external audits and regulatory inspections.
Validation Support
* Assist in the preparation, execution, and documentation of equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation activities.
* Maintain accurate and organized validation files and records.
* Track validation timelines and help ensure activities are performed in compliance with internal procedures.
Compliance and Documentation
* Review completed documentation for accuracy, completeness, and compliance with applicable standards.
* Support investigations for deviations, non-conformances, and CAPAs related to validation and quality activities.
* Help maintain calibration and maintenance records for critical equipment.
Collaboration & Training
* Work closely with production, engineering, and quality control teams to support operational needs.
* Participate in training programs related to cGMP, ISO standards, data integrity, and validation principles.