Experience: 05-09 Years

Designation: Executive/Sr.Executive

Qualification:M.Sc/M.Tech/B.Tech (Biotech/Biochemistry)

Role & responsibilities :

USP

- Execute upstream processing operations, ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
- Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
- Perform upstream processing activities, including vial revival, seed propagation, Media & Feed preparation, Bioreactors operation, and clarification process.
- Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR) and other GMP documents , maintaining up-to-date, accurate records.
- Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufactuing
- Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.
- Operate, manage & perform troubleshooting of all USP equipments, including RM, single-use bioreactors, depth filtration systems, pallet tanks, autoclaves, and IPQC equipment.

DSP

- Execute Downstream processing operations,



ensuring process consistency, product quality, and adherence to GMP guidelines and quality systems.
- Monitor equipment and process parameters to maintain consistency, reporting any abnormal observations or deviations to supervisors.
- Performing Downstream processing activities, including Chromatography, Virus inactivation, TFF, Virus removal, Buffer and solution preparation.
- Performing Resolute Column packing activity using Packing station.
- Operate, manage and perform trouble shooting of DSP equipment, chromatography systems, TFF system, Buffer preparation system and other downstream processing equipment
- Review and maintenance of Logbooks on shop-floor. Manage and submit cGMP documentation, including logbooks, batch manufacturing records (BMR), and other executed documents.
- Collaborate with cross-functional teams, including Engineering, Quality Control (QC), and Quality Assurance (QA), to support manufacturing
- Draft and update Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Standard Process Records (SPRs), and other GMP documents, supporting compliance and accuracy.

Please share your resume at [email protected] / [email protected]

📌 Executive/ Senior Executive For Drug Substance Manufacturing (Dhar)
🏢 IPCA
📍 Dhar