Canada Pharmaceutical jobs

POSITION: Senior Quality Assurance Associate

REPORTS TO: Director, Quality Systems/Manager, Quality

Systems/Manager Quality Assurance/Manager, Compliance/

SUMMARY OF POSITION:

The Senior Quality Assurance Associate is responsible to run and support activities within Quality

Operations, Systems and Compliance, including document control, change control, quality incidents,

CAPA, GMP data review, batch review for product release, internal audits, client audits, and supplier

quality management. The Senior QA Associate will verify operations, systems and compliance with Good

Manufacturing Practices and Quality Management System.

ESSENTIAL FUNCTIONS:

Providing guidance and oversight to a team of employees.

Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc.),

including reviewing, assessing the severity and approving minor incidents and outcomes of Phase 1

OOS investigations and participating in the investigations of major incidents.

Participating in the internal audit program and supporting external audit requirements.

Managing and leading changes to SOPs and supporting changes to SOPs made by other departments

through the change control review process.

Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.

Monitoring and enforcement of GMP requirements during day-to-day operations for all departments

within the company.

Supporting the supplier management program.

Inspecting and releasing rooms and performing facility inspections as part of general compliance

activities.

Preparing or assisting in the preparation of reports and protocols, including validation and

qualification.

Issuing, checking, and archiving QC notebooks.

Providing GMP and SOP training to various departments.

Managing product label masters and creation.

Supporting the CAPA program.

Supporting Analytical validation and process transfer activities, and the overall method and Analytical

process lifecycle by reviewing and approving analytical validation data and revising, reviewing and

approving protocols, reports and work instructions as needed.

Participating in the Pest Control program, including inspection and investigation.

Performing batch record review and data review for release of critical raw materials, active

pharmaceutical ingredients, and final products.

Supporting Process lifecycle by reviewing and approving creation and changes to batch records.

Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.

Adhering to BIOVECTRA’s Health and Safety Policy as outlined in CP0010 Occupational Health and

Safety Policy, Statements of Principle, and Responsibilities.

Additional duties assigned, based on business needs and the department supervisor’s request.

MINIMUM REQUIREMENTS:

Education:

Bachelor of Science degree.

Experience:

Five years of work experience with a food or drug manufacturing company, with

One year’s direct experience in a Quality Unit position.

Knowledge of cGMP, FDA, and Health Canada pharmaceutical regulations for API’s.

Experience with Regulatory Agencies

Preferred Skills/Qualifications:

Proficient communicator, both written and oral.

Able to work independently with minimal supervision as well as part of a team.

Efficient at prioritization and scheduling.

Critical thinker.

Effective presentation skills.

Excellent interpersonal skills.

LEADERSHIP COMPETENCIES:

Emotional Intelligence

Leverage Diversity

Organizational Intelligence

Develop Others

Facilitate Transformation

Pay: $35.00-$39.34 per hour

Work Location: In person