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Quality Systems Manager
2 weeks 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, nonconformances/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 recordkeeping 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 thirdparty 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 34 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 fastpaced environment
- Strong analytical and problemsolving 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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