Summary:
Validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Duties
- Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Oversees cleaning validation for program to ensure program adherence in accordance with approved schedules.
- Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Effectively communicate to key stakeholders on cleaning validation programs (program adherence, success rate, issues / roadblock.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Trains/advises less experienced Specialists.
- Manages projects and prepares status reports.
- May be required to oversee contingent workers.
- Other duties assigned by management.
Skills & Abilities:
- Ability to always maintain integrity and honesty
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Continuously drive to improve processes for improved performance
- Demonstrate respectful behaviour at all times
- Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)
- Gathers and organizes information
- Meets commitments on time
- Follows directions; performs well-defined tasks
- Effective time management skills
- Seeks to identify continuous improvement needs
Education
BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education
