Reporting to: Team Leader-Sterilization
Job Purpose
To supervise staff, monitor, and coordinate process control measures specifically in the sterilization section so as to ensure efficient output.
JOB ROLES AND EXPECTATIONS:
- To ensure continuous quality production by proper supervision of manpower, activities, and status of working machines in the department.
- To ensure proper batch-wise production & separation in the pre- & post-sterilisation areas by ensuring proper line clearance and status labeling.
- To follow up on the regular maintenance, validation, & calibration of production machinery.
- To ensure proper implementation of the cGMP guideline for all staff and support staff.
- To ensure adherence to good housekeeping practices and also monitor the cleanliness of equipment.
- To regularly plan and avail all materials required for daily operations of the section
- To participate in the process of preparing and reviewing SOPs and ensuring its implementation all the time.
- To ensure proper filling of information in the corresponding documents like BMR, sterilization logbooks, leak test logbooks, cleaning logbooks, and positive pressure records.
- To ensure good understanding & implementation of good documentation practices all the time
- To participate in the process of preparing and reviewing SOPs and ensuring its implementation all the time.
- To ensure proper filling of information in the corresponding documents like BMR, sterilization logbooks, leak test logbooks, cleaning logbooks, and positive pressure records.
- To ensure good understanding & implementation of good documentation practices all the time
- To efficiently plan for sterilization of products appropriately in case more than one product is in the process cycle.
- To ensure sterilization of clean room and dispensing garments within the clean room area
- To ensure minimum wastage of utilities like steam, cooling water, compressed air, electricity, etc.
- To conduct trainings for all new recruits in the department.
- To regularly conduct routine on-the-job trainings for all temporary employees and also update them on GMP guidelines.
- Ensure that any other duty assigned by the supervisor is executed to Management expectations
AUTHORITIES
- Reviewing the headcount of contract laborers shift wise and authorizing manpower in coordination with team leader.
- Executing and documenting all sterilization activities online.
- Training of casual workers before they are involved in production activities.
- Stoppage of filling machine if any out of specification results observed and confirmed in coordination with section head- filling.
- Instructing the BFS operators to rectify if any quality defect bottles are produced.
- Co-ordination with different sections in production for smooth running of activities.
COMPETENCIES
- Advanced science background
- CGMP knowledge
- Product knowledge
- Budget & planning
Behavioral / Attitude Competencies
- Analytical skills
- Effective communication
- Result oriented
- Team work
- Mature & assertive
MINIMUM QUALIFICATIONS / REQUIREMENTS
- Bachelor’s degree in Industrial Chemistry, Pharmacy, Chemical Engineering, Biological Sciences or any other related field.
- 2 years’ experience working in relevant / similar company
- Ability to work with senior people.
- Excellent report-writing skills
For the Job Application Process
Submission Details:
- Email Address: [email protected]
- Deadline: 30th December 2024, by 5:00 PM
Attach your CV and Academic Credentials. Late applications will not be considered.
We look forward to receiving your applications.
