QA Change Control
InterSources Inc
QA Change Control
This position supports the Pharmaceutical Quality Assurance department by performing Quality Assurance activities related to change control and validation associated with clinical and commercial products. Colleagues in this role should be able to demonstrate the following:
- Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) and Pharmaceutical Quality Standards to be a key contributor
- Contribute to the interpretation of cGMPs for commercial and clinical product
- Independently able to resolve issues and represents Quality Assurance in cross-departmental/cross-site meetings
- Good judgment and correct decision making based on Pharmaceutical procedures, PQSs, technical experience; and industry guidance/regulatory regulations
- Collaborates and independently engages with a wide range of co-workers, customers, and management within the OpU to gather the input and background knowledge needed to complete assignments
- Identifies issues and reports them to appropriate management attention immediately
- Identifies and takes remedial action or seeks advice when a person or project goal/deliverable is off schedule
- Ability to organize own work to meet project deadlines
- Ability to receive feedback from management and other colleagues takes accountability for actions and personal development
- Effective written and verbal communication and interpersonal skills
- Can generate metrics to support continuous improvement of the site
- Plan and execute projects
- Suggest improvements and participates in continuous improvement activities
- Interface with and represents Quality Assurance in cross-departmental and cross-site meetings, manage working area and projects/changes to accomplish change activities/project deliverables
- Responsible for prioritization and associated timely completion of activities/deliverables
- Support regulatory audits as needed
Vacancy posted 3 days ago
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