Career Connections Canada Inc.
"Connecting great people with great companies"
Job Type: Full Time, Permanent
Location: Brampton, Canada
The primary purpose is to provide expertise for the generation, execution, modification and summation of Validation documents of equipment (manufacturing and laboratory), processes, cleaning, sanitizing and facilities aspects of company manufacturing site that may affect the quality of the product produced or tested. This is accomplished through interaction and co-ordination of activities with all relevant departments within the organization.
Principal Duties and Responsibilities:
- Ensure validation programs are established and maintained and that Master Plan objectives and schedules are met working within the constraints established by the production schedule.
- Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). Ensure protocols provide: 1) a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes, 2) assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).
- Responsible and accountable for the execution of Validation Protocols including: 1) observation and documentation of the equipment or process, 2) collection of samples, 3) coordination of testing and 4) coordination of third party services.
- Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status.
- Write Validation related SOP’s or Policies as required.
- Evaluate new equipment from a validation perspective through participation on the equipment selection team with engineering to ensure that new purchases will be capable of meeting validation requirements.
- File and maintain Validation documentation archive ensuring prompt document retrieval when required.
- Manage effectively all assigned Validation projects.
- Train personnel on validation related SOP’s as required.
- Establish strong relationships inter- and intra-departmentally and provide leadership and guidance.
- Work proactively with other departments to ensure Validation requirements are met.
- Source/audit/evaluate/monitor third party services, if necessary, for Validation requirements.
- Complete all GMP Documentation correctly and in a timely manner
- Complete all training assignments and maintain personal training records
- Participate in and/or lead Non Conformance Investigations
- Complete Corrective and Preventive Actions (CAPA’s)
- Initiate, and follow through with actions required to close Change Controls
- Participate in Internal, Customer and Regulatory Audits
- Other duties as assigned
Knowledge, Skills and Abilities:
- Strong project management and communication /writing skills
- Proficient computer skills and broad technical knowledge are required in order to provide value-added input into the Protocol development and execution process and to understand and analyze technical systems (mechanical, electrical & scientific).
- Knowledge of the principles and application of current Good Manufacturing Practices guidelines related to Validation activities is essential, as is the ability to work both independently and in a team to achieve objectives
- Knowledge of Change Control Systems.
- Exceptional verbal and written communication skills
- Innovative mindset combined with strong problem solving ability.
- Bachelor’s degree in Natural Science or Engineering (mechanical or chemical preferred)
- Minimum 2 years of pharmaceutical or relevant technical experience.
** 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.