General Position Description:
This position is responsible for ensuring compliance on daily operations including but not exclusively site’s equipment calibration, preventive maintenance, premises compliance, and GMP documentation compliance. This role supports the effective control and compliance of all manufacturing and production operations, ensuring that facilities, equipment, processes, and associated systems remain in a controlled and compliant state in accordance with GMP requirements. The position plays a key role in inspection readiness, quality system effectiveness, regulatory compliance, and operational reliability across pharmaceutical, natural health product, medical device, and cosmetic manufacturing activities.
Responsibilities:
- Provide results-oriented leadership that drives continuous improvement consistent with the Companies Quality Objectives and all regulatory guidelines
- Engaging in continuous improvements with minimal disruptions to daily operations
- Verify equipment status, calibration intervals, and preventive maintenance schedules to prevent GMP impact or production delays.
- Assist with training process for personnel performing activities affecting compliance verification
- 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.
- 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.
- Immediately identify and communicate deviations, discrepancies, equipment failures, process abnormalities, or other conditions that may affect product quality or GMP compliance.
- 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.
- Verify production equipment, utensils, manufacturing rooms, filling areas, and associated production spaces are cleaned and sanitized in accordance with approved procedures.
- Maintain comprehensive operational knowledge of all production operations to provide support to staff and ability to cover personnel across functions as needed.
- Verify compounding manufacturing processes in pharmaceutical and cosmetic areas
- Verify production requirements prior to batch commencement to confirm appropriate personnel, equipment, materials, documentation, and room availability.
- Verify that batch records and other production documentation are completed accurately, contemporaneously, legibly, and in accordance with Good Documentation Practices.
- Ensure all products filing and packaging operations are performed in compliance with Master Production Document instructions, SOPs, and all other regulatory policies and guidelines
- Verify continuously throughout the day that staff are comprehensive of responsibilities on each production line
Knowledge, skills and work experience requirements:
- Strong understanding of GMP requirements and principles.
- Experience with calibration, preventive maintenance, facility compliance, and GMP documentation.
- Strong organizational, communication, and documentation skills.
- Strong attention to detail and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced, regulated environment.
- Ability to work independently and as part of a team with minimal supervision.
- Previous experience supporting manufacturing equipment, facilities, maintenance, or compliance activities is required.
Minimum of 2 years experience in the pharmaceutical manufacturing industry
Minimum of 2 years of practical, hands-on, on-the-ground, manufacturing experience
