Compounding Team Lead
Current• Performing strict adherence to non-aseptic manufacturing operations. • Verifying accurate formulation, calculation and measurements of chemicals using in batches.• Ensure validation and production protocols are written, executed and documented in accordance with Quality Policies and Regulatory requirements. • Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning. • Qualified to confirm that all bulk products meet QC standards prior to filling.• Ability to ensure all activities related to site GMP compliance and Precursor regulations are overseen by a team member and completed to meet GMP and Health Canada regulation requirements.• Assisted in the investigation of Out-of-specification (OOS) test results and root cause assessment.• Assisting in modification of SOPs and BPRs for new process in accordance with change control policies. • Evaluate issues related to the manufacture bulks and mechanical related tanks, pumps, quadro, homogenizer.• Involve in processing of validation batches and working with customer batches.• Monitor and support the execution of the production through training, facilitating and problem solving activities. • Well trained in WHMIS, first aid, CPR and rescues – confine space.
