Plastikon Healthcare is looking for a Change Control Manager is responsible for control of change in all site GMP facilities, utilities, equipment, and documentation and oversight of change for key non-GMP facilities, utilities, equipment, and documentation. Responsible for quality oversight of changes to product components, containers, closures, and finished products. Responsibility includes continuous efforts to upgrade and improve the interface in current systems and conversion to new electronic systems upon approval from site and Company management.
- Ensure that the change control and document management quality systems are consistent with Company policies, procedures, and cGMPs.
- Management of the change control system.
- Responsible for conducting Change Control Review Board (CCRB) on a specified frequency to review and make decisions on change control deliverables.
- Responsible for issue resolution for change control activities. Make and guide decisions on classifications of changes and change control deliverables required to complete a required change.
- Management of the Change Control group to ensure timely and compliant change control packages. Develop and provide metrics for the change control quality system for Management Review.
- Provide oversight of electronic systems for change control activities. Make and guide decisions on changes and system requirements for product lifecycle management related to change control, product changes.
- Responsible for quality reviews of validation records for validated systems and processes; shared responsibility with quality groups.
- Work on special projects as they arise.
- Other duties as assigned.
- Bachelor’s degree from an accredited college or university is required. Degree in Technical field (e.g., Chemistry, Biology, Microbiology, or Engineering) preferred.
- Minimum 5 years of Quality experience in pharmaceutical or allied industry.
- Minimum 2 years of supervisory/management experience.
Skills & Abilities
- High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment.
- Must have thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
- Must have good organizational, presentation, project management, communication, and meeting facilitation skills.
- Knowledge of a wide variety of change control and documentation systems is preferred.
- Required reading, writing, and speaking fluently in English.
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time.