What are the responsibilities and job description for the Manufacturing QMS Specialist position at Kashiv BioSciences LLC?
Job Type
Full-time
Description
Requirements Essential Duties & Responsibilities :
- Responsible to support manufacturing team with all kinds of documentation.
- Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
- Responsible for filing change controls, deviation, CAPA for manufacturing department.
- For all critical / major investigation, will have to use investigation tools like 5why or 6M method.
- Attend daily meetings with both upstream and downstream process to get all the documentation requirement for the day.
- Meet weekly with QA to avoid any delay in the QMS closure.
- Author batch records, SOPs and associated forms / formats required for manufacturing process.
- Responsible for requesting / submitting all GMP documents to QA.
- Support manufacturing process (night shifts, weekends, holidays) during critical campaign.
- 10% wet lab work.
- Performs other functions as required or assigned.
- Complies with all company policies and standards.
Requirements
Education and Experience :
Special Skills :
