About this role
About the Role The QA Officer ensures quality oversight over GMP activities at the site, contributing to hygiene, validation/qualification status, training, and quality documentation. This role is responsible for provisional release of batches, shifting with other QA officers, and maintaining compliance with GMPs and Health Authority requirements at the local level. What You'll Do
- Supervise the general hygiene conditions of the premises under management.
- Contribute to assuring the validation/qualification status of the production site, equipment, training of personnel, and management of quality documentation.
- Responsible for provisional release for the shipment of batches.
- Work in shifts with other QA officers to oversee production and quality control activities.
- Archive and support management of site GMP documentation; review batch records and ensure timely closure of manufactured batches.
- Maintain the local quality system per GMPs and corporate guidelines; ensure compliance with GMPs and Health Authority requirements at local level.
- Support the QP in preparing batch release documents.
- Collaborate in redaction of site GMP documentation and in preparation/printing of batch documentation.
- Collaborate in data compilation of Product Reviews; oversee investigations and monitor resulting actions.
- Participate in self-inspections per approved annual plan. What We're Looking For
- Experience in GMP environments with QA oversight, batch release, and GMP documentation.
- Knowledge of batch records review, product release processes, and QP collaboration.
- Ability to work cross-functionally with production, QA, and regulatory/compliance functions.
- Experience with audits and self-inspections.
- Flexibility to work in a site-based (onsite) setting and in shift rotations.