Contact Information

T: (905) 363-1182 x 261
F: (905) 542-7981

TF: 1 (877) 877-5152 x 261
E: jbellavia@qualityandcompliance.com

2550 Argentia Rd., Suite 119,  Mississauga ON  L5N 5R1
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Manager, Compliance Services

John Bellavia is a Quality Assurance leader with extensive experience in the pharmaceutical industry, with areas of expertise in: Quality Systems, Quality Audits, Change Management, Serialization, Root Cause Analysis and CAPA Determination, Process, Packaging and Cleaning Validation, Packaging Component Testing and Release, and Facility, Equipment and Utility Qualification. John has a proven track record of partnering with operational teams to increase throughput, while achieving quality targets, and leveraging technical expertise in manufacturing and packaging to provide robust and timely riskbased decisions.

Skills and Highlights

Project Manager/Manager

  • Led a department of 37 Quality Assurance personnel in support of the compliance and business needs of a packaging and labeling operation
  • Implemented 24 hour/7 days a week, Quality Assurance shop-floor coverage to support packaging line operations without increasing headcount, by optimizing procedures and eliminating non-value added activities
  • Managed the ongoing activities of the packaging component laboratory, that was responsible for the approval, testing and disposition of all labeling and packaging components
  • Spearheaded changes to testing profiles and composition of packaging containers used in finished pharmaceutical products, resulting in a savings of $600K/year in testing and material costs
  • Reduced cycle times for release testing of printed components by 60% by developing and implementing streamlined test procedures
  • Provided QA leadership to contract manufacturers for the development of active pharmaceutical ingredients (API) and finished products for use in company R&D programs
  • Developed and implemented SOPs for the release of API and clinical trial materials manufactured by third party manufacturers and packagers
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Quality Assurance

  • Authored, implemented and maintained global policies and guidelines related to equipment, facility and utility qualification
  • Provided training and implementation assistance to multiple locations for one client
  • Developed corrective actions to compliance gaps
  • Provided Quality oversight and approval of change controls, deviations, customer returns, and rework

Audits

  • Conducted GMP audits for API and finished product contract manufacturers to ensure compliance with regulatory and internal requirements
  • Hosted customer and regulatory audits of the Quality Assurance department
  • Audited validation programs to identify gaps to company policies and GMP regulations

Validation

  • Provided leadership, guidance and regulatory compliance expertise for equipment, facility and utility qualification queries
  • Directed all process validation activities at contract manufacturing sites for solid dose and biological products
  • Critically reviewed and approved validation master plans, protocols and reports generated at contract manufacturers to ensure compliance with corporate validation policies
  • Developed, implemented and maintained site validation master plans

Education

  • Doctor of Philosophy (Ph.D.) – Organic Chemistry, McMaster University, Hamilton, ON
  • Bachelor of Science, Honours – Chemistry, McMaster University, Hamilton, ON