Douglas Matzko Email & Phone Number

Toronto, Ontario, Canada

Etobicoke, Ontario, Canada

Etobicoke, Ontario

Toronto, Canada Area

Toronto, Ontario

Reviewing and assessing Request for Changes (RFCs) including assigning impact assessors, developing implementation plans and QA approval to proceed with changes.

Toronto

Managed and ensured the compliance of projects related to process and cleaning validation including review and approval of proposed validation documentation and strategies which ensure the validation program remains compliant with Health Canada, Food and Drug Administration (FDA) and other regulatory agencies.

Brampton, Ontario

Provides expertise for the generation, execution, modification and summation of Validation documents of manufacturing equipment, processes, cleaning, and sanitizing that may affect the quality of the product produced. This is accomplished through interaction and co-ordination of activities with all relevant departments.

Identified, organized and controlled project elements. Identified and assigned appropriate project resources. Monitored and reported project progress at regular intervals. Managed cross functional meetings and followed up on actions. Ensured all activities are completed in a compliant manner.

Contributed to the development of Technical Acceptance Criteria during technology transfer. Identified Critical Process Parameters and Critical Quality Attributes, ensuring that these are understood, controlled and verified. Developed specifications for active pharmaceutical ingredients and excipients in conjunction with suppliers. Worked closely with.

Prepared, reviewed, approved and executed performance qualification protocols and validation reports. Assessed manufacturing process planned changes for their impact on validation. Responded to queries from Regulatory authorities, third party auditors and internal auditors.

Project management, system justification, creation and implementation of computer validation deliverables for laboratory equipment and systems, following the conventional validation lifecycle approach.

Supervised and led the work of a team in a Quality Control lab by identifying and resolving issues, maintaining a safe healthy and legal work environment, providing feedback and coaching to analysts. Maintained compliance to SOPs, GMPs and Policies. Performed all responsibilities of the Alternate Qualifies Person in Charge (AQPIC). Created and reviewed.

Routine and non-routine chemical and physical analysis of pharmaceutical raw materials and products according to GSK specifications and various pharmacopoeia requirements. Data analysis and investigation of Out-Of-Specification (OOS) results. Trained new analysts.

Bsc, Biochemistry & Microbiology

Introduction To Validation