Responsibilities:
- Ensure adherence to the Change Control management systems and processes.
- Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed.
- Evaluate Change Control requests for process, validation, regulatory and product impact.
- Coordinate the review and approval process of change requests to ensure timely execution of changes.
- Ensure all site changes are managed appropriately to meet the expectation of the global change control board (if applicable) and meets site project timelines.
- Participate in cross functional and cross site change management forums.
- Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process.
- Ensure completion of required change control actions prior to lifting lot disposition restrictions.
- Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications.
- Perform Change Records review in support of Annual Product Review activities.
- Ensure maintenance and continuous improvement of change control and processes.
- Support regulatory inspections and provide audit support with team, which may include presentations and facility, utility, equipment documentation review.
- Compliance with cGMP and site safety & security regulations at all times
- Any other duties as assigned by supervisor or manager.
About You:
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- 3+ years of experience in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment.
Duration: 12-months contract role
