William Thomsen Email & Phone Number

Schaumburg, IL, US

Responsible for qualification and validation approvals (in a quality role). Conducted bi-weekly change control meetings. Responsible for quality review of periodic reviews. Assigned change control assessors. Provided quality pre-approval of change controls. Generated weekly change control metrics.

Andover, Massachusetts, US

Compliance ConsultantQuality Assurance representative on Technology Transfer projects. Assisted in data transfer activities.

Dallas, TX, US

Shire, Los Angeles, CAQualified a variety of manufacturing equipment (IQ/OQ). Performed commissioning activities on the WFI system. Performed DeltaV alarm and interlock testing.Pfizer, Kalamazoo, MIReviewed SAT packages for new sterile fill line.

Responsibilities: Developed and executed cGMP qualification and commissioning documents (IQ/OQ) for pharmaceutical and biotechnology manufacturing, processing and computerized systems. Conducted quality audits of test plans, deviations and final reports. Document and close deviations including determining the root-cause and implementing effective.

London, United Kingdom, GB

• Provided a number of engineering and regulatory compliance services to clients in the pharmaceutical, biotechnology and chemical industries.
• Drafted audit documentation for cyber-security audit program.
• Completed two client site cyber-security audits.
• Developed audit final report and presented findings and remediation suggestions to client management.
• Validated installation and operation of four manufacturing facility Building Automation systems which integrated and controlled thousands of individual components.
• Performed document audits of completed Manufacturing Execution System test protocols in support of an FDA Pre-Approval Inspection of a vaccine production facility.

Cambridge, GB

• Provided a number of engineering and regulatory compliance services to clients in the pharmaceutical, biotechnology and chemical industries.
• Supported development of a Risk-Based validation / qualification strategy for a major biotechnology company.
• Participated in the qualification of a manufacturing facilities’ Building Automation System.
• Verified correct layout of electrical panels.
• Calculated sterile vial filler product contact surface area.
• Determined total allowable carry-over of chemical residue for a sterile vial filler.

Virum, Capital Region, DK

• Provided client firms with quality assurance and regulatory compliance services in cGMP manufacturing environments.
• Development and execution of qualification and validation test protocols.
• Review, auditing and development of SOPs, procedures, policies and training records.
• Qualification and validation of clean water utility generation and distribution systems (Purified Water, Water for Injection).
• Audit of line clearance procedures for adequacy and effectiveness.
• Verification of interlock systems.

Blue Bell, PA, US

• Provided qualification and validation services to clients in the pharmaceutical industry.
• Developed Installation and Operational Qualification documents for a variety of equipment used in the manufacture of finished pharmaceutical products.
• Tested pump and transfer rates.
• Verified material of construction through the use of direct chemical tests.
• Checked gasket material of construction.
• Conducted manufacturing tank (fixed and portable) heating and cooling tests.

Bachelor Of Arts (Ba), History

Bachelor Of Arts (Ba), Humanities/Humanistic Studies