Perform comprehensive and detailed investigations relating to manufacturing/packaging, complaints, OOS investigations and analytical failures to ensure compliance with GMPs, GLPs and OSG WIs and SOPs
Generates validation protocols and reports
Create/issue QA protocols for sampling and/or inspections and lead AQL evaluations
Work collaboratively with site operations in the resolution of GMP deviations
Liaise with Operations, QC, Regulatory Affairs, other QA teams, Manufacturers, Suppliers, Customers, to obtain necessary information/documentation required for product review/release/investigations
Provide clear QA guidance
Work with various operational departments to negotiate, follow up and facilitate the completion of CAPAs
Review and approve out-of-specification investigations and provide impact assessments
Review and release of finished products
Attend meetings and participate in decision making, issue resolution, coordination of work assignment and work reporting, drive for timely completion of investigations and implementation of CAPAs for self and team
Review and provide feedback on investigations and procedures for team members
Review and approve IQ/OQ and Validation protocols
Participate in internal Quality Assurance audits
Participate in Health Canada, FDA and NSF audits
May participate in the quality inspections and audits of outsourced manufacturing facilities and supply chain
Preparation, compilation, writing and review of international registration dossiers. These include, but not limited to original submission registrations, renewals, notifiable change, supplements, class labeling, annual DIN notifications, variations and written responses to queries
Perform other duties as assigned
Qualifications
Technical writing abilities and good time management
Strong root cause analysis skills with GMP experience
To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required
Nutritional, Dietary Supplement, functional food or related industry product development, technical and formulation
Troubleshooting abilities desired
Proficient in MS Word, Excel, and PowerPoint
Self-motivated and willing to be proactive in resolving issues
Excellent Verbal and written communication skills
Ability to work in a team environment
Ability to manage, train and create an effective and positive team environment
Highly organized with sense of urgency and ability to prioritize workload in fast paced environment
Ambition, self-motivation, eagerness to learn, positive attitude and a commitment to continuous improvement
Ability to manage workflow pressures and competing priorities
Bachelor of Science preferred
Previous experience in a pharmaceutical manufacturing environment and/or knowledge of GMP/GLP would be an asset.
