As a Qualification Validation Specialist, you will act as a Consultant on a remote and/or hybrid mode engagement opportunity.
Duties and responsibilities include, but are not limited to:
- Creating qualification (IQ/OQ/PQ) test protocols.
- Ensuring documentation aligns with URS and PPQ plan.
- Preparing and executing validation documents.
- Project execution for multiple systems validation.
- Understanding the hours budgeted for completion of each task on a specific.
- Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
- Develop Installation, Operational and simple Performance qualification documents.
- Qualified candidates will possess a Bachelor’s degree in related field along with 3 plus years related industry experience.
- Candidates must have excellent verbal communication and technical writing skills.
- Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
- Familiarity with many aspects of validation is expected.
- Strong understanding GxP (US FDA, Health Canada, EMA, etc.) requirements
- Experience with temperature mapping.
- Proficient in Microsoft Word, Excel, Power Point and Project.
- Must be willing to travel
- Bilingual : French and English
- Working Onsite and Remotely
- Must be able to travel occasionally
- Quebec, Canada
|Job Category||Commissioning & Qualification (CQV)|