The Equipment Qualification Specialist is responsible for the management and conduct of the equipment qualification activities at Lucy Scientific Discovery Inc. (LSDI) and subsidiaries to ensure that equipment performs as intended. This position reports to the Chief Operating Officer (COO) and/or designate.
Roles and Responsibilities
The following are the principal roles and responsibilities of the Equipment Qualification Specialist:
- Management and conduct of equipment qualification (EQ) activities at LSDI and subsidiaries to ensure compliance with applicable regulatory requirements including Good Manufacturing Practice and other regulations and guidelines as applicable to the business operations of the company.
- Develop and implement corporate EQ strategies and objectives for compliance with applicable regulations and guidelines.
- Develop Standard Operating Procedures (SOPs).
- Perform and/or oversee all aspects of EQ including planning and developing qualification strategies, creation of all required documentation and performance of the qualification in conjunction with the equipment owner(s) in accordance with SOPs and applicable procedures.
- Create documentation including validation plans, testing protocols (IQ/OQ/PQ) and validation reports.
- Manage the change control process to support all qualification activities.
- Provide guidance and support to Operations with focus on both new and ongoing qualification initiatives.
- Perform staff training.
- Work with Operations to ensure successful and effective implementation of EQ strategies.
- Report the status of EQ activities to the COO on a regular and timely basis.
- Maintain current knowledge of the industry landscape to ensure that LSDI’s EQ programs fulfill changing and evolving industry, regulatory and client needs.
- Other duties as required.
Minimum level of education:
Post-secondary degree in a related discipline or equivalent
Minimum level of employment experience:
5+ years of experience in an EQ role in a pharmaceutical GMP finished product and/or API manufacturing environment
Excellent management and interpersonal skills. Ability to interact professionally with diplomacy. Sound decision-making abilities based upon regulatory knowledge with business sensibilities.
There are no special working conditions.
There are no special physical requirements.
Health and Safety Responsibilities
All employees shall work according to the provisions outlined in the Occupational Health and Safety Regulations in addition to the safety policies set forth at LSDI. All employees shall ensure that personal protective and safety equipment are appropriately used as required and that safety policies and SOPs are followed by employees.