- Provide assistance with quality-related minor deviations, escalations, and material disposition on the shop floor with no clean room requirements.
- Finalise the review of formulation, manufacturing, bulk packaging, and inspection records to guarantee adherence to Good Manufacturing Practices GMP.
- Supply support to the Product Quality Engineer for continuous improvement initiatives relevant to the assigned tasks.
- Assist in supplying direction concerning batch disposition and major deviations.
- Enable internal audits to detect and address any GMP faults.
- Facilitate walk-throughs of operational sections and survey processes to make sure GMP acceptability, cleanliness, organisation, and control.
- Aid the Quality Validation Manager with change and validation activities that could impact product and/or process.
- Help facilitate alterations to Standard Operating Procedures, Work Instructions, specifications, and similar documents.
- Work alongside the Contract Manufacturing Organisation to collect and report quality metrics on a monthly basis.
- Offer instruction and training for new and existing employees.
- Ensure that Annual Product Reviews have been produced and assessed according to regulations and on time.
- Assure that all Quality Technical Agreement criteria are being met.
- Take part in reviews, investigations, and responses for product quality complaints.
- Fulfill any other tasks mandated by the management authority to serve the North America Quality team.
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
To find out more about Real please visit www.realstaffing.com
