Level
Associate/ Senior Associate
Location
Bengaluru, India
Work Location
Doddaballapura, Bengaluru
Exp & Qualification
M.Sc/ M pharma with 2-8 Years of relevant experience.
Primary responsibilities
- Responsible for DP facility manufacturing activities like operation of isolators and associated equipment related to cartridges, vials & and pre-filled syringes.
- Assist with the installation, commissioning, and qualification activities like IQ, OQ, and PQ of Filling lines.
- Ensure QMS compliance in qualification and manufacturing-related activities.
- Assist with the validations of all the equipment and area and the aseptic media fill.
- Identify and implement the manufacturing procedures with compliance to current GMP requirements.
- Responsible for daily cleaning and disinfectant preparation activities
- Ensuring implementation of workplace safety-related procedures/Primary protective equipment (PPE).
- Performing SAT of equipment at our facility.
- Assisting in the validation/ routine validation of equipment and facility.
- Prepare of all SOPs/protocols related to equipment and drug product facility.
- Identify and implement the manufacturing procedures with compliance to current GMP requirements.
- Timely initiation of QMS elements.
- Completion of SAP-related transactions (as applicable) related to functional work.