Specialist, Compliance QA

Apotex•Brantford, ON

About The Position

Development, execution and maintenance of effective Quality Systems and ensuring Compliance, to corporate and global drug regulatory agency requirements. Responsible for supporting Quality Culture through Compliance and Quality System program/system scheduling, execution and monitoring for effectiveness. Ensures their work complies with health and safety standards, SOPs, cGMP and regulatory requirements.

Requirements

Education at the University level in a related scientific discipline.
Strong practical knowledge of pharmacopoeial requirements and other related regulatory guidelines.
Detail-oriented with strong analytical, investigative and technical report-writing skills.
Effective communication (verbal and written) skills.
Demonstrated effective project coordination/management and leadership skills.
Good knowledge of statistical data analysis.
Strong proficiency in computer applications and programs such as Word, Excel and Project Management related software.
Good understanding of API manufacturing environment.
Proven experience in effective auditing techniques covering documentation, system operations, and operational activities in pharmaceutical environment.
Minimum seven years of regulatory compliance and quality experience in the Pharmaceutical Industry (ie. Regulatory, QA, etc.) with focus on quality systems.
Strong practical experience in interpretation and application of cGMP pharmaceutical regulations and guidelines (Canada, USA, ICH), with focus on quality systems.
Experience in developing and delivering CGMP training.
Experience in maintaining complete and accurate documentation/records/data, filed in an organized, secure and easily retrievable manner.

Responsibilities

Manages audit program by scheduling and leading self-inspections. Ensures appropriate corrective and preventative actions are taken to close-out of the audit reports.
Co-ordinates and schedules supplier and third-party audits/assessments in accordance with the approved schedule/ program.
Conducts external audits.
Develops, schedules and delivers the on-going GMP training and certification programs.
Performs effectiveness checks.
Ensures required training records are maintained.
Establishes & tracks completion of the Annual Product Review Program to the annual schedule.
Compiles or coordinates the report.
Manages the Vendor Qualification Program by reviewing and approving documentation.
Coordinates the reduced testing program.
Coordinates the Product Complaint & Returned Goods system.
Conducts, reviews and approves investigations, product/quality system impact assessments and CAPA plans.
Monitors effectiveness of the investigations & CAPA program; prepares routine reports; evaluates trends; and implements improvements.
Writes, updates and reviews Standard Operating Procedures and risk assessment reports.
Completes compliance impact assessments and participates in or coordinates implementation of major system changes.
Co-ordinates operational or systematic changes through Change Control.
Approve/review Change controls, as designated.
Develop and prepare periodic Quality Unit & QMS performance metrics and trend reports.
Makes recommendations and implements corrective measures/improvements.
Coordinate statistical analysis including maintaining data, control chart creation and trending of product quality and process data.
Acts as representative on continuous improvement projects including Quality and Compliance Awareness programs.
Provides leadership, co-ordination, and project management as required.
Reviews current and proposed regulatory guidelines and regulations and provides impact analysis for Management review.
Develops and executes plans for implementation of changes or new regulatory requirements.
Participates in customer and regulatory body inspections.
Contributes to responses, tracking and reporting commitment status.
Provides technical support to customer queries, GMP questionnaires, review of customer specifications/methods, coordination of customer quality agreements, and approval of contract testing results.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.