|Paris, Ontario - Canada
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WHY IS THIS A GREAT OPPORTUNITY?
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Our client in Paris, ON, is actively seeking a qualified candidate to fill the role of Validation Specialist, reporting to the Senior Manager of QA.
- 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.
- Collaborate with internal stakeholders to ensure equipment is qualified/re-qualified and processes are validated/re-validated as required and according to schedule.
- Identify deviations from established process or equipment standards and provides recommendations for resolving deviations.
- Manage effectively all assigned Validation projects.
- Provide training specific to validation protocol requirements for sampling, to the production department
- Train company personnel on validation related SOP’s as required.
- Establish strong relationships inter- and intra-departmentally and provide leadership and guidance.
- 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.
- and qualification principles, industry trends, or novel technologies.
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
- Familiarity with regulatory requirements with respect to validation and qualification activities in pharmaceutical industry.
- Certification in Project Management, while not required is considered a plus.
- Knowledge of GMP, Health Canada and ISO.
Skills & Abilities
- Systems and process thinker who understands the importance of continuous improvement and how it fits within the Quality Management System and Risk Management.
- Previous experience in process design, flow mapping, writing and conducting process validations and equipment qualifications.
- Demonstrated ability in project management and project management tools.
- Strong computer skills (Word, Excel, PowerPoint, Visio, etc).
- Must be well organized.
- Exceptional listening, communication, analytical and problem-solving skills.
- Ability to handle multiple priorities and a dynamic changing environment.
- Able to bring innovative solutions to process and equipment design and flow mapping.
- Flexible, adaptable and previous experience in a fast-paced environment.
- Strong relationship-building capabilities.
- Collaborative, team-oriented and versatile.
- Other duties as assigned
- May be required to stay on site for extended periods of time.
- Variety of working environments including all areas of the office and plant.
- Occasional exposure to the smell of cannabis, chemicals and higher or lower than normal temperatures, humidity and light exposure.
- On occasion flexible hours of work may be required to support Validation Protocol execution.
- Some lifting may be required, up to 25 lbs.
- Routinely a mixture of standing/walking/sitting are required.
University - Bachelor's Degree/3-4 Year Degree