Denis Moiseenko Email & Phone Number

Canada

Kitchener, Canada Area

Kitchener, Canada Area

Kitchener, Canada Area

- Perform Management and Technical Audits as per ISO 17025 requirements, conduct post-audit meetings as necessary- Perform GLP/GMP inspections to ensure compliance to protocols and regulatory specifications- Prepare reports to include audit findings, perform investigations to determine the root cause of the problem and propose corrective actions- Handle.

Mississauga

• Scheduled, conducted and reported on findings of ISO 17025 and GMP Internal Audits for different laboratory departments and critical systems. Provided guidance and addressed raised non-conformance reports (NCRs) /.
• Facilitated client, FDA and Health Canada site audits
• Developed and implemented Operational and Performance Qualification (OQ/PQ) protocols and Standard Operating Procedures (SOPs) for stability chambers, fridges and freezers; conducted temperature and humidity mapping.
• Acted as a technical writer and reviewer for company’s policies, SOPs and instrument qualification protocols
• Qualified Person in Charge (A/QPIC) – authorized by Health Canada to maintain inventory of controlled substances under company’s license for analytical testing purposes
• Acted as a primary custodian for essential laboratory equipment and services – Milli-Q Water System, stability chambers, Environmental Monitoring System and Measuring Instrument Inventory (MII) Database. Conducted.

Mississauga

• Responsible for inventory management of chemicals, standards and Controlled Substances
• Researched and ordered chemicals, supplies and equipment required for successful completion of projects; conducted quote negotiations and met with suppliers to establish successful business partnerships
• Acted as a primary custodian for Stability Chambers, MilliQ Water and Centron Monitoring System
• Developed and implemented Operational and Performance Qualification (OQ/PQ) protocols and Standard Operating Procedures (SOPs) for stability chambers, fridges and freezers; conducted mapping and calibrations
• Overseen equipment maintenance and investigated out-of-tolerance reports; coordinated preventative maintenance and repairs with subcontractors

Mississauga

• Responsible for ordering and maintaining an inventory of a wide range of chemicals, standards, equipment and consumables for all laboratories in the Health Sciences group
• Researched and ordered supplies needed for new projects
• Reviewed new projects upon their arrival and communicated effectively with clients and management to settle any discrepancies; updated them on the status of orders
• Managed MilliQ Water System as the primary custodian of the system
• Maintained compliance to all health and safety standards, Good Manufacturing Practices (GMPs) and regulatory requirements
• Assisted the sample reception team with data review and client contacts

Mississauga

• Employed current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) for testing and quality assessment of pharmaceuticals according to USP, EP, ACS, FCC and NF monographs
• Utilized FT-IR and UV-VIS spectroscopy, refractometry, dissolution and wet chemistry for the identification and quantitative analysis of chemical samples
• Prepared test and laboratory solutions and performed their volumetric analysis, consistently achieving results within a narrow standard deviation
• Worked as part of a team to provide accurate and reliable results to a vast range of customers while meeting tight deadlines