Resolute Workforce Solutions is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change.
We serve businesses in a wide range of industries including Pharmaceuticals, Medical Cannabis Food & Beverage, Chemicals, and Information Technology.
We are always looking for highly motivated and energetic individuals with experience in Process, Equipment, Computer, Cleaning and Thermal Validation.
DISCLAIMER THIS ISNOTAN ACTIVE POSTING.
By applying to this job your profile will be considered for upcoming roles within the next 1-6 months Responsibilities :
Conduct review and approval of risk assessment, validation protocols and reports.
Conduct review of technical specifications, standard operating procedures and production batch documentation, systems and equipment validation.
Be responsible for quality oversight for the project deliverables and support activities.
Develop, implement, and manage quality operations and revalidation procedures to meet cGMP and regulatory requirements to ensure that programs are compliant with inspection agencies’ requirements and Company Quality policies.
Establish and maintain the Validation Master Plan(s) (VMP).
Maintain overview of state of validation at site and establish the project prioritization across site.
Liaison with other cross-functional departments to ensure project deliverables is completed.
Bachelor of Science or relevant technical field in Engineering
Minimum 4 years of hands on experience in and thorough understanding of validation life cycle (commissioning and validation concepts, strategy, GMP and 21CFRPart11) in the pharmaceutical, biotech or medical device industries
Strong working knowledge of facilities, equipment and regulatory requirements across multiple health authorities (e.g.
FDA, Health Canada, EU)
High level of familiarity with MS Office package (Microsoft Project, Powerpoint, Excel, Word).