General Position Description:
This position is responsible for coordinating and overseeing the site’s equipment calibration, preventive maintenance, premises compliance, and GMP documentation update compliance. This role ensures that manufacturing, warehouse, filling and packaging systems remain in a validated and controlled state in accordance with GMP requirements. This position plays a key role in inspection readiness, quality system effectiveness, and operational reliability across pharmaceutical, natural health product, medical device, and cosmetic operations.
Responsibilities:
- Coordinate and maintain site calibration and preventive maintenance programs
- Ensure calibration and maintenance activities are executed in accordance with approved SOPs, schedules, and GMP requirements.
- Maintain equipment status, calibration intervals, and preventive maintenance schedules to prevent GMP impact or production delays.
- Identify and provide training for personnel performing activities affecting quality.
- Verify ongoing compliance of manufacturing, laboratory, warehouse, and utility areas with GMP premises requirements, ensuring facilities are suitable for their intended use.
- Conduct routine GMP and premises inspections in accordance with SOPs to assess cleanliness, equipment condition, maintenance status, environmental controls, and material/equipment flow.
- Ensure equipment, utilities, and premises are maintained in a state of control to support product quality and regulatory compliance.
- Identify, document, and escalate GMP and premises deficiencies, and support the development and implementation of corrective and preventive actions (CAPAs).
- Support inspection readiness activities and participate in regulatory and internal audits as required.
- Maintain adherence to company policies and safety standards including ensuring that manufacturing facilities, the warehouse and surrounding areas are organized and meet cleanliness and safety requirements.
- Maintain a strong understanding of all production operations to provide support and coverage across functions as needed.
Primary Documentation Verification Back-up – Key Duties and Responsibilities:
- Verify activities are performed in compliance to manufacturing work instructions within quality approved Master Production Documentation.
- Documentation verification on compounding manufacturing activities
Knowledge, skills and work experience requirements:
Strong understanding of GMP principles, with demonstrated experience supporting calibration, maintenance, and premises compliance in a regulated environment.
Excellent organizational, communication, and documentation skills with strong attention to detail.
Sound problem-solving and analytical abilities, particularly related to equipment and facility-related GMP issues.
Ability to manage multiple priorities and remain effective under time-sensitive and inspection-driven conditions.
Ability to work independently and collaboratively with minimal supervision.
Previous experience coordinating calibration, preventive maintenance, premises compliance, or GMP documentation activities is required.
Minimum of 2 years experience in the pharmaceutical industry
Bachelor of Science Degree in Chemistry or Biochemistry.
