Quality Systems Manager
6 days ago
**Overview**: Reporting to the Director, Quality Assurance, the Team Lead, Compliance will provide exceptional support as an important contributor to the compliance team. As a critical quality function, this role will be responsible to drive and maintain the day-to-day operations of quality system. In this role, the Team lead, Compliance will support the team to conduct investigations, solve complex issues using critical thinking and established investigational techniques.
**Scope of Role**:
- Lead investigation of complaints, non-conformances/deviations and CAPA.
- Lead training activities related to Quality
- Assist with development and maintenance of the company’s quality systems and internal programs, ensuring compliance with applicable Health Canada regulations
- Collaborate with other departments on change controls
- Assist in developing, reviewing, and maintaining SOPs, QMS, and projects to ensure compliance under the Cannabis Act/Regulations
- Responsible for management of internal documentation according to regulations and internal policies.
- Maintain QMS by performing record-keeping tasks such as document updates and change controls.
- Support internal regulatory compliance by working with interdepartmental teams to establish and/or improve processes by reviewing and/or providing input regarding existing Standard Operating Procedures (SOPs), controlled forms and policies.
- Support internal compliance initiatives as required under Health Canada regulations and guidance.
- Participate in the internal audit program, conduct internal audits, and prepare observation reports.
- Provide quality support during regulatory inspections and third-party audits.
- Assists in developing and writing SOPs, protocols, and preventive control plans, ensuring compliance with the _Cannabis Act _and GPP/GMP.
- Other tasks as assigned.
**Knowledge and Experience**:
- Minimum 3-4 year of relevant experience is required in Quality Assurance and Compliance
- Bachelor’s Degree in Chemistry/Biochemistry/Biology/Food Science/Pharmacy related science
- Experience working in a regulated environment, pharmaceuticals, food, and/or NHP manufacturing
- Experience in Quality Management Systems (QMS), Preventative Control Plans, and Regulatory Submissions will be an added advantage.
**Required Competencies**:
- Solid MS Office Excel, Word and PowerPoint skills
- Excellent written and verbal communication skills
- Solid team player who promotes a culture of professionalism, integrity, quality and teamwork
- Demonstrated ability to lead and influence the thinking and actions of others
- Ability to prioritize workload in a fast-paced environment
- Strong analytical and problem-solving skills
- Experience working within a highly regulated environment
- Comfortable to follow best practices and keep all required documentation update to date
**Job Types**: Full-time, Permanent
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: One location
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