SPECIFIC SKILL REQUIREMENTS
- Minimum of 2-3 year experience in Manufacturing environment
- Familiarity with cGMPs
- Pharmaceutical manufacturing experience
- AS degree in science (Biology, Microbiology or related science)
- Bachelor’s degree in Sciences
- Good aseptic techniques
- Good documentation skills
- Good computer skills
- Technical writing skills
- Aseptic gowning qualification
- Strong collaboration skills with other departments (i.e. production, quality control, validations)
- Must be able to manage competing priorities
- Ability to communicate effectively defending quality initiatives and compliance
Samples clean steam samples, RO water samples, pretreatment water samples, water for injection.
The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
Perform environmental monitoring of the controlled production rooms, i.e., air sample monitoring, surface monitoring, non-viable particle counts.
Perform personnel monitoring of production operators using contact plates; this requires coordination with production personnel.
Reading plates if needed.
Perform environmental monitoring of aseptic filling operations (class 100).
Train personnel on aseptic gowning and aseptic behaviour.
Document work in master production records, logbooks, data sheets, as applicable.
Participate and write environmental notifications and deviation investigations, as applicable.
Prepare and revise standard operating procedures.
Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
Perform Line clearance and Line release for compounding and filling.
Train personnel for tasks mentioned above.