Career Connections Canada Inc.
'Connecting great people with great companies'
Our pharmaceutical client in Brampton is seeking a Senior Manager, Quality Engineering to join their team.
Reporting To: Associate Director, Quality Operations
Responsible For: Quality Assurance oversight for Critical Engineering Systems, Automated Equipment Computerized System Interfaces and Site Wide Calibration and Maintenance Programs
Develop systems and procedures and provide QA leadership/oversite for engineering, equipment/utilities/facilities technologies and calibration and maintenance programs to ensure sustained compliance in accordance with cGMP, company policies and regulatory requirements.
The position is responsible for oversight and management of the Quality Systems that support Engineering, Calibration and Maintenance programs such as change controls, non-Conformance Investigations, annual calibration, preventive maintenance, repairs, and environmental monitoring of facility.
Principal Duties and Responsibilities:
- Develop and Implement Quality standards for Engineering, Calibration and Maintenance Controls in compliance with Regulatory and Engineering Industry Practice.
- Ensure that all activities related to new equipment/facility projects, upgrade of existing systems or planned modifications are in compliance with company and regulatory requirements;
- Ensure QA support activities related to new product launches, process transfer, scale-ups, equipment projects, upgrade of existing systems or planned modifications are in compliance with company and regulatory requirements; comply with the local and corporate SOPs & policies
- Perform risk analysis and assessments on the engineering, calibration and maintenance systems;
- Provide QA oversight and monitoring of equipment calibration and preventive maintenance program and the engineering and technical aspects of the environmental monitoring program of HVAC, compressed air, water and temperature.
- Review and approve engineering documents;
- Review qualification documents
- Monitor and approve annual calibration and preventive maintenance program; review and assess repair activities; approve SOP, Forms, Technical and Engineering drawings;
- Provide oversight for the calibration frequency and criticality of equipment and instruments; approve calibration specifications, procedures, forms, and reports;
- Manage change control system for equipment, laboratory instruments; approve change control requests, issue tasks and verify their implementation and effectiveness;
- Ensure that all activities related to the assignment, completion and approval of calibration, preventive maintenance and repair are done in compliance with company and regulatory requirements.
- Review for completeness and approve appropriate corrective & preventative actions (CAPA); ensure their implementation and effectiveness;
- Participate in and/or lead Non Conformance Investigations
- Support or lead facility inspection, audits (internal audits program or regulatory inspections);
- Manage the monitoring program for temperature and humidity and manage the mapping program including thermal validation;
- Perform critical systems periodical review and re-assessment (Purified Water, HVAC, Compressed Air);
- Monitor the equipment engineering calibration and maintenance databases and utilize the program for tracking and trending activities.
- Track metrics related to the equipment calibration and maintenance program, provide updates to Site Quality Council when necessary
- Review and approve policies and procedures as required
- Ensure the computer systems validation as per CRF Part 11 and Annex 11 regulations for all automated equipment and facilities.
- Other duties as assigned
Knowledge, Skills and Abilities:
- Strong management skills
- Sound knowledge and application of Health Canada and FDA regulations
- Excellent communication, negotiation and interpersonal skills
- Strong organizational skills
- Excellent written and verbal communication skills
- Good organizational skills and multi-tasking ability
- Minimum of B.Sc chemistry or other associated discipline
- More than 8 years experience in a pharmaceutical industry environment
- Excellent interpersonal skills and communication skills (verbal and written)
- Previous management skills required and demonstrated managerial ability
- Good knowledge of GMP and regulatory requirements for the pharmaceutical industry
- Organizational ability to maintain a complex and high volume project management environment
- Ability to effectively analyze problems, exercise sound judgment and make timely decisions
- Ability to meet established project timelines in a timely manner
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.