Quality Assurance Supervisor

Job Description: Quality Assurance Supervisor (Day Shift- Fulltime-Onsite)

Qualifications

· Bachelor's degree in Science.

· Minimum of 7 years of relevant experience in a GMP and cGMP manufacturing environment in the pharmaceutical Industry.

· Strong communication and leadership skills.

· Effective team management and collaboration skills.

· Knowledge of statistical methods and tools for quality improvement.

· Ability to adapt to a fast-paced and dynamic work environment.

· Positive attitude with problem-solving skills and a proactive approach.

· Ability to interpret and understand application requirements and regulations.

Responsibilities

• Provide supports on managing and maintaining compliant Quality Management System.
• Ensure all the processes and activities from Supplier Qualification, Importation of API, Manufacturing, packaging, testing and labeling, and distribution are performed in compliance with regulations and organization requirements and standards as well as internal SOPs.
• Ensure all the changes are handled through change Control program and the changes are communicated, assessed for impact on processes and documents before implementation.
• Manage product documentation as defined in the SOPs
• Ensure all the staff are trained properly by qualified trainers, trainings are documented and maintained, and the training is verified for effectiveness.
• Monitor Supplier Qualification and ensure supplier receipt of required documentation from suppliers and vendors.
• Ensure inventory is complete and accurate and distribution and traceability log are maintained properly, updated and are correct.
• Support the preparation and review of validation protocols and reports including transportation, temperature mapping, and stability or freeze-thaw studies;
• Support and coordinate activities for audits with regards to the preparation, conduct and follow-up.
• Supervise that the environmental monitoring program is performed properly.
• Ensure that products received are transported, handled, sampled, stored, and destroyed in accordance with requirements and correctly;
• Ensure complaints are investigated and follow-up actions (e.g. CAPAs, change control, market actions) are implemented and their effectiveness assessed;
• Manage sample tracking, label assessments and reviews
• Supervise and monitor labeling and packaging material usage and storage
• Review and approve documents of high complexity including manufacturing validation protocols and reports, master batch records and investigations
• Generate and approve Finished Product and Stability Specifications ensuring product compliance with market authorizations, specifications or monographs, as applicable
• Support and follow-up of CAPA action plans, deviations and out-of-specification investigations
• Reconcile GMP and CGMP documents for product lots requiring QC disposition (Label Reviews, Batch records, Certificate of Analysis and Certificate of Manufacture,)
• Coordinate required confirmatory testing and stability for products
• Perform, analyze and interpret data trends from drug and natural health product stability programs;
• Other Quality Control duties, as required, to ensure ongoing compliance with Health Canada and FDA requirements and the achievement of applicable goals and objectives.

Job Types: Full-time, Permanent

Salary: From $70,000.00 per year

Benefits:

• Dental care
• Employee assistance program
• Life insurance
• On-site parking
• Paid time off
• Vision care

Flexible Language Requirement:

• French not required

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's Degree (preferred)

Experience:

• Quality Assurance: 1 year (preferred)

Ability to Commute:

• Durham, ON (required)

Ability to Relocate:

• Durham, ON: Relocate before starting work (required)

Work Location: In person