About this position
Description:
RequirementsEssential 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.
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Education and Experience:
- A Minimum BA or BS in Biological Sciences or related technical field is required.
- Minimum 5 years of experience in Biopharmaceuticals.
- Knowledge in USP and DSP process
Special Skills:
- Ability to work with other team members and independently - good interpersonal skills.
- Good communication skills: verbal and written, good computer and organization skills, detail oriented.
- Basic computer skills, including knowledge of Word, Excel, and spread sheet.
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation.