We are a fully integrated pure-play biologics Contract Development and Manufacturing Organization (CDMO), offering the complete spectrum of services, from cell line technology transfer to clinical and commercial manufacturing with capabilities to convert drug substance into stable formulations and fill and finish formats. We have proven technical expertise in microbial, mammalian, viral vectors, and various other technology platforms with world-class cGMP manufacturing facilities that offer high-quality services for your global programs.
Post : Associate / Senior Associate - Drug Product – Manufacturing
Job Description
• 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.
Candidate Profile
M.Sc / M.Pharma with 2-8 Years of relevant experience.
Additional Information
Experience : 2-8 Years
Qualification : M.Sc/ M.Pharma
Location : Doddaballapura, Bengaluru, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Manufacturing
End Date : 30th April 2024
Email your resume to : J.DhanaVignesh@stelis.com | Email subject: DP manufacturing - Stelis
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