T: (905) 363-1182 x261
TF: 1 (877) 877-5152 x261
2550 Argentia Road, Suite 119, Mississauga, ON L5N 5R1
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John Bellavia, Manager Compliance Services
John Bellavia is a quality assurance leader with extensive experience in the pharmaceutical industry, and 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 risk-based decisions.
Skills & Highlights
- 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, which 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
- 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 customer
- Developed corrective actions to compliance gaps
- Provided Quality oversight and approval of change controls, deviations, customer returns, and rework
- Supervised laboratory equipment qualification, calibration, and preventative maintenance programs.
- 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
- 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.
- Developed and validated analytical methods using a wide variety of instruments including: HPLC, GC, dissolution, UV-Visible spectroscopy, and IR spectroscopy.
- Doctor of Philosophy (Ph.D.) – Organic Chemistry, McMaster University, Hamilton, ON
- Bachelor of Science, Honours – Chemistry, McMaster University, Hamilton, ON