Our client in Paris, Ontario, is actively seeking a qualified candidate to fill the role of Validation Specialist.
Reporting to the Sr. Quality Assurance Manager. 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 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.
- Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process).
- Ensure protocols provide:
- a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes,
- assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).
- Responsible and accountable for the execution of Validation Protocols including:
- observation and documentation of the equipment or process,
- collection of samples,
- coordination of testing and
- coordination of third party services.
- Perform change control assessment and determine impact to validation equipment and processes.
- 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.
- 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.
- Apply statistical methods (as required) in process validations and equipment qualifications
- Maintain Validation documentation archive ensuring prompt document retrieval when required.
- Write Validation related SOP’s or Policies as required.
- Participate in and/or lead Non Conformance Investigations
- Complete Corrective and Preventive Actions (CAPA’s)
Experience / Education
- Degree in a relevant field, such as: Pharmaceuticals, Biotechnology, Engineering, Manufacturing, Quality Assurance, Quality Control, Laboratory Sciences Certification as a Quality Engineer, Process Analysis, Continuous Process Improvement, LEAN or Six Sigma considered an asset.
- 3 to 5 years of experience in Validation, with experience in equipment qualification, process and cleaning validation.
- 2 to 5 years of experience of working in Production/Quality department in pharmaceutical manufacturing environment
* 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..