Quality Assurance Manager
Olds, AB, Canada
Job Description
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Olds Softgels Inc. is a fast-paced, international manufacturer of pharmaceutical, and cannabis products. We currently have an opening for a full time, career-oriented individual to serve as a Quality Assurance Manager at our facility in Olds, Alberta. 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 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
- Bachelor\xe2\x80\x99s Degree in a related scientific field.
- Experience in a quality position within the pharmaceutical, food, natural health products, or cannabis industry considered to be an asset.
- Knowledge of Cannabis Act and its Regulations.
- Adept at problem solving, project management and strong communication skills with an excellent attention to detail.
- Proven analytical and creative thinker with the ability to adapt to changing priorities and deadlines.
- Ability to work independently.
- Proficient user of excel and word.
- Ability to manage workflow pressures and competing priorities
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- Paid time off
- Vision care
- 8 hour shift
- Olds, AB: reliably commute or plan to relocate before starting work (required)
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Job Detail
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Job IdJD2154726
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationOlds, AB, Canada
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EducationNot mentioned