Quality Assurance/Validation Manager
Job Type: Full-Time Wage: NEG
Quality Assurance/Validation Manager responsibility will be to establish optimal documentation collection, tracking, retrieval and archival to support GMP compliance activities management processes. The Quality Assurance/Validation Manager will also be responsible for releasing of finished products by reviewing and archiving relevant batch record documentation as well as managing retained samples. Validation responsibilities will include generating validation protocols and reports, compile data and helps identify the testing that will be used during the validation activities. In addition, small scale formulation and filling experience is desired.
Specific Job Duties:
- 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
- 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.
OSG offers competitive compensation, a benefit package and opportunities for advancement.
If you would like to work for a dynamic, fast-paced, global manufacturer please submit your resume to firstname.lastname@example.org.
OSG does not offer a relocation package.