FAQs
What are the environmental conditions for the Sterile Operator role?
The role requires adherence to Good Manufacturing Practices (GMP) and safety standards in a cleanroom environment, where hair products, jewelry, makeup, nail polish, perfumes, exposed piercings, and facial hair are not allowed. Some degree of Personal Protective Equipment (PPE) is required, including safety glasses, gowns, gloves, lab coats, and ear plugs. The position also requires standing for the full shift.
What are the main responsibilities of a Sterile Operator?
The main responsibilities include operating production machines outside and inside the sterile area according to Batch Records and SOPs, cleaning machines after production activities, completing Batch Records and departmental documentation, loading filling lines, preparing filters for testing, cleaning the sterile area, ensuring material availability, caring for equipment and work environment, conducting chemical and microbiological sampling, performing mechanical interventions on machines, and maintaining aseptic practices.
Is prior experience necessary for this position?
While specific requirements for prior experience are not mentioned, familiarity with GMP practices, cleanroom environments, and relevant machinery operations will be advantageous for candidates.
What kind of training is provided for a new Sterile Operator?
Training will be provided on Good Manufacturing Practices (GMP), operating specific machinery, following Standard Operating Procedures (SOPs), and maintaining aseptic conditions, as well as any other relevant practices necessary for the role.
Are there specific qualifications required for this position?
The job description does not specify particular qualifications, but candidates with backgrounds in manufacturing, pharmacy, chemistry, or related fields, along with an understanding of GMP and cleanroom protocols, will likely be preferred.
What is the work schedule for a Sterile Operator?
The work schedule for a Sterile Operator is unspecified in the job description, but it generally involves working shifts that require full-time presence in a cleanroom environment.
What personal hygiene practices must be followed in this position?
Personal hygiene practices in this position include not using hair products, jewelry, makeup, nail polish, and perfumes, and having no exposed piercings or facial hair, to maintain the sterility of the environment.
What kind of Personal Protective Equipment (PPE) is required?
Required PPE includes safety glasses, gowns, gloves, lab coats, and ear plugs to ensure safety and maintain cleanliness in the sterile environment.
How is performance evaluated for a Sterile Operator?
Performance evaluation for a Sterile Operator may involve assessing adherence to SOPs, efficiency in completing tasks, accuracy in documentation, and overall compliance with GMP and safety standards.
What should I do if I notice an anomaly with the machinery or work environment?
If you notice any anomalies with the machinery or work environment, you should communicate them promptly to your supervisor to address the issue.