Greg Davies Email & Phone Number

Winnipeg

Production walk-through of manufacturing/production area’s to ensure that all regulations, SOP’s and documentation practices are being followed. Host/lead the audits performed on the manufacturing/production area’s and systems. Training of employee’s on regulations and documentation practices (also classroom training ). Address SOR’s and complete follow-up with the production operators. Ensure all audit findings are addressed and completed in a timely manner. Investigate and record non-critical and critical deviations discovered and ensuring follow-up and appropriate supporting documentation is completed. Change controls will be completed to write new procedures, improve the process or to stay current with the revision. Review production batch records as required, to assure technical integrity and compliance with cGMP,s, SOP’s, specifications and approved current master production documentation. Work and develop relationships with EN, PR, QA, QC or warehouse to resolve any issues that might arise. Work with production manager and production coordinator on SOR follow-up, CAPA, investigations and internal and external audits. Research Engineering, Production and QA data systems to retrieve relevant information. Review and complete bin card activity. Place work orders as needed.

Winnipeg, Manitoba

Quality/Compliance Specialist, Apotex Fermentation Inc., 2019-2019 Ensures knowledge of regulatory requirements are current, maintain awareness of industry issues trends and changes within regulations. Reviewed and approved batch records, protocols, QC results, change controls and investigations. Designed, developed and delivered GMP training to the facility on regulations and documentation practices. Perform visual inspections of final product before shipment from the facility. Investigate and resolve investigations ensuring follow up and ensure all documentation is completed. Support complaint handling investigations. Reviewed all final products prior to Managers release.  Conducted Audits for both internal and external sources. Certified and issued batch records. Completed all investigations, deviations, out of calibration, out of trends and training deficiencies. Trended all investigations, deviations, out of calibration, out of trends and training deficiencies. Provide QA support for regulatory submissions. Support validation with the review of executed records and written reports.

Winnipeg, Canada Area

Quality/Compliance Specialist, Apotex Fermentation Inc., 2019-2019 Ensures knowledge of regulatory requirements are current, maintain awareness of industry issues trends and changes within regulations. Reviewed and approved batch records, protocols, QC results, change controls and investigations. Designed, developed and delivered GMP training to the facility on regulations and documentation practices. Perform visual inspections of final product before shipment from the facility. Investigate and resolve investigations ensuring follow up and ensure all documentation is completed. Support complaint handling investigations. Reviewed all final products prior to Managers release.  Conducted Audits for both internal and external sources. Certified and issued batch records. Completed all investigations, deviations, out of calibration, out of trends and training deficiencies. Trended all investigations, deviations, out of calibration, out of trends and training deficiencies. Provide QA support for regulatory submissions. Support validation with the review of executed records and written reports.

Winnipeg, Canada Area

Quality/Compliance Specialist, Apotex Fermentation Inc., 2019-2019 Ensures knowledge of regulatory requirements are current, maintain awareness of industry issues trends and changes within regulations. Reviewed and approved batch records, protocols, QC results, change controls and investigations. Designed, developed and delivered GMP training to the facility on regulations and documentation practices. Perform visual inspections of final product before shipment from the facility. Investigate and resolve investigations ensuring follow up and ensure all documentation is completed. Support complaint handling investigations. Reviewed all final products prior to Managers release.  Conducted Audits for both internal and external sources. Certified and issued batch records. Completed all investigations, deviations, out of calibration, out of trends and training deficiencies. Trended all investigations, deviations, out of calibration, out of trends and training deficiencies. Provide QA support for regulatory submissions. Support validation with the review of executed records and written reports.

Winnipeg

Quality/Compliance Specialist, Apotex Fermentation Inc., 2019-2019 Ensures knowledge of regulatory requirements are current, maintain awareness of industry issues trends and changes within regulations. Reviewed and approved batch records, protocols, QC results, change controls and investigations. Designed, developed and delivered GMP training to the facility on regulations and documentation practices. Perform visual inspections of final product before shipment from the facility. Investigate and resolve investigations ensuring follow up and ensure all documentation is completed. Support complaint handling investigations. Reviewed all final products prior to Managers release.  Conducted Audits for both internal and external sources. Certified and issued batch records. Completed all investigations, deviations, out of calibration, out of trends and training deficiencies. Trended all investigations, deviations, out of calibration, out of trends and training deficiencies. Provide QA support for regulatory submissions. Support validation with the review of executed records and written reports.

Winnipeg

Review production batch records.Assist with GMP Practices.Assist with training practices.Auditing the department.Investigating deviations.Making supervisory decisions.Writing change controls.

Reviewed and approved batch records, QC results, change controls.Reviewed all final products prior to Managers release. Conducted Audits and GMP training for the facility.Certified and issued batch records.Designed and developed training programs for GMP training.Completed all investigations, deviations, out of calibration, out of trends and training deficiencies.Completed reports as required through various investigations.Trended all investigations, deviations, out of calibration, out of trends and training deficiencies.Daily walk throughs of manufacturing.

Created Engineering Studies and Process Validation Protocols for new and existing products. Prepared all applicable reports associated with Engineering Studies and Process Validation Protocols.Monitored blending, compression as well as coating procedures in the manufacturing area.Completed all physical tests associated with the Engineering Studies and Process Validation Protocols.Reviewed various reports and protocols to ensure adherence to GMP policies. Completed and organized the Process Validation Library.Performed Environmental Monitoring for both facilities (Beghin and Debaets) for 3 months. Experience with Solabs documentation system.Product development.

Scheduled, coordinated and facilitated Introductory and Refresher GMP training for new and current employees (450 employees trained in 2004).Created and developed introductory and refresher training modules for new employees.Conducted training initiatives for new policies/procedural improvements - train all employees within one week (safety charter - 550 employees) (gowning procedure - 600 employees).Conducted internal audits and assisted with final reports for GMP and Health & Safety for the facility.Maintained training database and generate GMP certificates.Active member of the safety committee.

Trained a new employee on test methods and procedures.Reviewed pharmaceutical samples on Chemistry, Chromatography and Dissolution.Reviewed raw materials, in-process, stability, finished products and equipment calibrations.Prepared for internal and external audits.Knowledge of USP products and test methods.Created Global Training System for QC.

Trained co-workers on various equipment in the lab.Tested all pharmaceutical samples on FTIR, Karl Fischer, Dissolution, UV assay, PH and Viscosity.Knowledge of USP and the use of their test methods (i.e. Heavy metals). Created and maintained a visual library of defects for reference.

Supervised a team of eight on the night shift one year intermittently.Trained analysts, production workers and sales representatives on formulating, test methods and procedures.Responsible for producing new coating formulations for production scale up.Established new product design and development.Worked with management and customers to design and develop new formulations.Ordering supplies and equipment.Wrote internal and external reports.

Supervised a team of eight in the manufacturing sector for one year.Trained analysts, production workers on formulating and testing of products.Analysed raw materials and finished products.Designed and developed new products for production.Consulted and wrote reports.

Diploma, Biological Technology

Masters Certificate, Project Management, A-