Quality Systems Specialist
3 weeks ago
**COMPANY BACKGROUND**:
Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.
**POSITION** **SUMMARY**:
The Quality Systems Associate will provide support for the Quality Assurance, Quality Control, Validation and Regulatory Affairs functions with various activities including data compilation, reports, Quality System records and submissions. This individual will also champion the document and training management systems and oversee the electronic quality management system (eQMS) including quality metrics. To be successful in this position, the individual must have strong organizational skills, attention to detail and technical knowledge or experience in a Quality function.
**ROLE SPECIFIC RESPONSIBILITIES**:
- Coordinate the electronic quality management system (eQMS) including reporting and monthly/quarterly metrics for the deviation, CAPA, change control, product complaint, internal audit systems. Manage the user task scheduler and ensure timely completion of assigned tasks
- Champion the document management system including document retention, lifecycle management and periodic reviews
- Champion the training module within the eQMS system for setting up new individuals, curricula, training requirements, quizzes and following up when training has reached minimum requirements for document updates
- Perform deviation investigations to identify root cause and corrective actions
- Work as part of the Quality Assurance team promoting a quality culture within the company SUPPORT:
- Initiate and conduct preliminary product complaint assessments including manufacturing record reviews and sample analysis in conjunction with the Quality Specialist and Quality Assurance Person
- Assist the Quality Operations team with issuance and compilation of batch records for review and release.
- Assist the Quality Operations team with line clearances for various production/packaging processes.
- Assist to compile and analyze data from Quality Control and generate internal and final
release CoAs as required
- Assist the Validation team to compile data for analysis and review reports or documentation as a quality reviewer.
- Assist the Regulatory Affairs team with document updates, preparing submission documents and other duties as assigned by the QA Manager
**Required Skills**:
- Document management and change control experience is required, preferably within pharmaceutical field
- Strong technical writing skills to support development and review of SOP's and associated documents
- Experience in Quality Systems: Change Control, Deviation, CAPA, Document Control
- Ability to work with all levels of the organization
- Ability to build strong relationships with internal and external customers
- Demonstrated and proven knowledge of domestic and international regulatory and GMP requirements
**Required Qualifications**
- Bachelor's degree or college diploma in a science related field
At MediPharm Labs we offer:
- Be part of the foundation of a new, growing industry and make your mark
- Autonomy and key decision-making opportunities
- Work in a fast-paced, collaborative environment with opportunity for growth both personally and professionally
MediPharm Labs is committed to providing accommodation for applicants with disabilities in its recruitment processes. If you require accommodation at any time during the recruitment process, please contact 705-719-7425 ext. 1080.
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