1. Strong knowledge in Aseptic formulation and filling operations
2. Adherence to production schedule.
3. Hands on experience in manufacturing of human vaccines in a reputed regulatory approved facilities.
4.Involvement in formulation activities (Blending) as well as line clearances & monitoring of the batch execution and Strong knowledge in Aseptic formulation
5. Responsible to monitor & ensure the execution of assigned jobs by his team members.
6.Empowered to take decision during execution of the blending process in compliance manner with all the stake holders
7.To ensure compliance of the facility, process, personnel and documentations with cGMP all the time and make facility ready for the audit all the time
8. Online completion of the documentations during execution of activities.
9. Involvement in Quality management systems viz.: Event Investigation and CAPA management, Change control management.
10.Strict adherence to HSE policies and Safety PEP talk discussion with the shop floor persons.
11.Knowledge in CIP, SIP processes and their trainings to team members
12.Timely communication of requirement of consumables to supervisors.
13. Basic Knowledge in computer system validations
14.Shift supervision to provide the practical execution of the batches & online documentation to all the team members
15.Responsible to prepare documents (SOP’s, BMR’s, and protocols).
16.Handling of shop floor shift activities and effective communication to superiors and Co-team members and Handling of automated equipments
17.Review of executed batch manufacturing records & in time submission for batch release
18.Shop floor Trainings
19.Ensure that facility, equipment’s and instruments are in validated, qualified and in calibrated status and make facility ready for the audit all the time.
20.Excellent communication & technical skills
21.Knowledge of regulatory compliance and documentation needs
22.Language requirements: English, Telugu, Hindi.
23.Qualifications & Experience required : M.Pharm / M.Sc. with 6 to 8 years of similar experience
24.Computer Skills: SAP, LIMS and LMS.
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.