Job Description :
Main requirements:
Write, review, and approve Investigations, OOS, CAPAs and Change Controls
Effectively communicate with peers and colleague’s status of investigations and recommendations for timely closure
Monitor for quality related issues and coordinate resolutions
Create visual materials/presentations
Review and monitor Quality metrics and reports trends
Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols and other QA controlled document under a Quality Managed System (QMS)
Interact with internal customers and provide support where needed.
Support internal and external audits
Work on customer complaints
Bachelor’s degree with 3-7 years’ experience in GMP manufacturing, validation, QA, QC, or other functional area applicable to the job or an Associate’s degree with 5-9 years applicable GMP experience in the specific QA job function as deemed appropriate by QA Management.
Knowledge and skills:
Technical writing skills
Proper execution of root cause analysis processes and tools
General understanding of Q7 (current) Good Manufacturing Practices.
Good computer skills, including proficiency MS Word, MS Excel, MS Access
Good time management skills
Knowledge of electronic document management systems (EDMS)
Excellent interpersonal skills for interacting with many internal departments.
Ability to organize and prioritize tasks effectively
Capacity for independent work