Formulation : Production Operator (L1-1)
Responsibilities:
- Handling & Operation of formulation vessels, filtration skids and supporting equipment as per standards and procedures
- Ensure the execution of media fills and all periodic validations in formulation area
- Responsible for Batch manufacturing and aseptic filtration
- Performing CIP/SIP of equipment and filtration skids
- Perform the filter integrity tests
- Execution of process validations, cleaning validations in formulation area
- Execution of batch as per BMR
- Ensure the necessary documentation work related to formulation area and formulation equipment
- Responsible for reporting any equipment breakdowns/quality/HSE related events
- Ensure the HSE and 5S at work place
- Maintain proper communication with in the department and between departments
- Responsible for timely issue the required materials from warehouse
- Ensure the area and equipment with good housekeeping standards and hygiene
- Ensure the online documentation in working area with all necessary supporting documents to comply the batch manufacturing records
- perform the cleaning of all processing equipment
- Carryout all quality checks/line clearance in formulation area
- Responsible to prepare SOP’s related to formulation area and supporting equipment
- Prepare and maintain GMP documents as per the departmental requirement
- Flexible to come in all shifts
- Ensure to comply the weekly/monthly/periodic schedules for the formulation area and equipment
- Responsible for work closely with shift manager and production manager
- Responsible for audit compliance in his area
- Responsible for part of investigation team
Knowledge Skills and Competencies
- Excellent verbal and written communication skills in English are required
- Flexible in nature towards work
- Basic GMP knowledge
- Experience in handling of liquid filling machines preferably with isolators
- Experience in filling machine changeovers
- Knowledge on CIP, SIP & Filter integrity
- Audit facing skills
- Analytical, Presentation, & Problem solving skills
- SME in his working area
- Trending of data (Environmental, CPP’s)
Qualification & Experience:
- Qualification: Bachelor or Master Degree in Pharmacy/Biotechnology
- Minimum of 3years to max of 4 years of Sterile injectable manufacturing /Sterile API manufacturing,
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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