Richard Robinson Email and Phone Number

• Managed the Validation department, supervising staff and overseeing the day-to-day operations.• Led regular monthly and quarterly meetings with cross-departmental teams to track and assess multiple concurrent projects. Involved in multiple technical product transfers and product launches from commissioning to commercialization.• Represented the Validation Department as the Subject Matter Expert reviewing all change controls, such as, but not limited to, revisions to or new Packaging and Manufacturing Work Orders, material changes and introduction of new products and/or equipment.• Served as department lead in External and Internal audits with Regulatory bodies and new/existing clients. • Primary approver for technical documents for the Quality department and Final Approver for over 500 IQ/OQ ‘s, Validation protocols and reports, Change Controls, Incident Reports, preventative maintenance and facilities schedule changes and all relevant SOP’s documentation.• Oversaw and maintained key company policy documents such as the Validation Master Plan and Cleaning Validation Risk Assessment.• Engaged employees through individual and group team building skills, training, coaching and outlining clear expectations to ensure timely deliverables.• Assisted in implementing the QRM approach for cleaning validation as per Health Canada’s Cleaning Validation Guidance.

• Prepared and executed no less than 75 cleaning, bulk hold time and process validation protocols/amendments and generate summary reports documents in accordance with GMP’s and Contract Pharmaceuticals Limited’s Validation Master Plan.• Performed validation impact assessments for proposed changes to validated processes.• Performed and documented cleaning validation assessments to identify new worst-case products for the cleaning validation program.• Maintained and updated the Validation Master Plan and Cleaning Validation Risk Assessment documents.• Ensured all relevant validation projects were performed in full compliance with current Good Manufacturing Practices, Standard Operating Procedures and government regulatory agency requirements and safety standards.• Coordinated and scheduled validation work with various departments while optimizing efficiency and minimizing delays.• Performed Cleaning Validation Verification and Effectiveness studies using various concentrations of the cleaning agent to challenge effectiveness of the cleaning procedures to meet the approved acceptance specifications.• Conducted Spiking Studies to evaluate and determine the effectiveness of the Visual Detection Limits requirements.• Conducted routine Product Containment studies to evaluate and quantify the amount of residual Active Drug Residue present airborne. • Conducted Coupon Recovery Studies for other Materials of Construction other than Stainless Steel to evaluate and compare recovery factors

• Designed cost effective, marketable, compliant, and viable package configurations to support Site Packaging Operations and related projects. Led the bottle consolidation project to optimize packaging line efficiency and reduce the time used for line change – over by 63%.• Provided technical knowledge for the development, procurement and troubleshooting of packaging materials and components to support site packaging operations• Created and updated relevant Standard Operating Procedures and templates to reflect ongoing changes to the Packaging Validation program. Implemented and maintained various packaging validation databases, tracking logs and matrices. • Wrote and updated Master Packaging Orders. Reviewed and approved 100% of change control request forms to ensure all changes to validated processes are evaluated in GMP and cGMP environments and that all documentation meets all regulatory requirements.• Troubleshot, investigated, and resolved packaging related problems. Developed action plans to improve processes and increase packaging efficiency. Conducted stability trials when required due to a change of components.• Prepared, executed trial protocols to determine runnability of product on the Packaging line. Line trials results and observations were summarized in a thorough yet concise report.• Validation protocols and final reports were generated to confirm optimal parameters to use for commercial production. Deviations were assessed and recommendations were made regarding the impact of the study.

• Wrote, reviewed and executed packaging validation protocols and updated current packaging batch documents in accordance with Health Products and Food Branch Inspectorate, Food and Drug Administration and European Union regulations and standards.• Coordinated and scheduled validation work with various departments while optimizing efficiency and minimizing delays.• Ensured all relevant validation projects were performed in full compliance with current Good Manufacturing Practices, Standard Operating Procedures and government regulatory agency requirements and safety standards.• Evaluated the packaging validation program and proposed alternative and improved program initiatives to ensure program compliance.• Implemented and maintained various packaging validation databases, tracking logs and matrices.• Updated and created relevant Standard Operating Procedures and templates to reflect ongoing changes to the Packaging Validation program.• Provided technical support to various departments as the validation representative.• Initiated, executed and assisted with Deviation Reports/Non-Conformance Reports investigations and Corrective and Preventative Actions. • Developed a methodology for Packaging Technology trials and created trial templates for both bottling and blistering processes

Managed the cleaning and packaging validation programs.-Wrote, reviewed and executed cleaning, manufacturing and packaging verification and validation protocols.-Supervised packaging validation batches, compiled packaging and cleaning data and summarized results in a written validation report.-Audited packaging batch documents and reviewed residual active and detergent and microbial Certificates of Analysis-Coordinated and scheduled validation work with various departments in accordance with HPFBI, FDA and EU regulations and standards while optimizing efficiency and minimizing delays.-Provided 24 hour technical support to packaging and manufacturing departments.-Wrote and updated current packaging batch documents.-Evaluated validation, sampling and testing requirements for commercial and technical transfer manufacturing and packaging batches.-Ensured all relevant validation projects were performed in full compliance with current GMP, SOP and government regulatory agency requirements and safety standards.

Worked within the Packaging Department assisting packaging operators and mechanics.-Dismantled, cleaned, sanitized and assembled equipment according to Standard Operating Procedures to ensure GMP/cGMP compliance and meet department changeover targets in support of reliability and productivity targets.-Correctly completed all documentation as per SOP and GMP/cGMP requirements.-Safely operated all required machinery and equipment and effectively.-Processed batches within specifications to meet department targets by ensuring optimal run rates.-Troubleshot mechanical issues with packaging machinery and assist mechanics with repairs.

Worked in and assisted the Technical Service Department as a summer student with full technologist responsibilities for TWO FULL SUMMERS-Wrote and assisted in the execution of technical service protocols.-Assisted Senior Technologist with scale up batches, trial batches for process improvement and process development for assessment.-Wrote and updated Standard Operating Procedures in accordance with FDA, EU and HPFBI regulations and standards.-Compiled all batch data and summarized results in a Technical Service Report.-Prepared documentation for Technical Transfer submissions to HPFBI, FDA and EU regulatory agencies.-Managed and coordinated Technical Service batches with various departments

Worked in and assisted the Coating Department as a summer student with modified responsibilities.-Dismantled, cleaned, sanitized and assembled equipment according to Standard Operating Procedures and GMP/cGMP standards.-Correctly completed all documentation as per SOP and GMP/cGMP requirements.-Safely operated all required machinery and equipment and effectively.-Processed batches within specifications to meet department targets by ensuring optimal run rates.