Walk-in | Executive / Sr. Executive - DS Manufacturing

Ipca; Pithampur; Presencial; INR 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Ipca in Pithampur requires an Executive/Sr. Executive to support upstream and downstream pharmaceutical processing. You will execute upstream activities, monitor processes, and ensure GMP compliance while maintaining accurate documentation and cross-functional collaboration with Engineering, QC, and QA teams.

The role also covers downstream processing tasks, equipment troubleshooting, and maintaining shop-floor logs, with emphasis on cGMP document integrity and continuous process improvement.

Formación

• MSc/MTech/BTech in a relevant discipline.
• Experience in upstream or downstream processing and GMP.
• Knowledge of cGMP documentation and record-keeping.

Responsabilidades

• Execute upstream processing operations, ensure process consistency and product quality under GMP.
• Monitor equipment and process parameters; report deviations to supervisors.
• Carry out upstream activities: vial revival, seed propagation, media/feed prep, bioreactors operation, clarification.
• Prepare and maintain cGMP docs: logbooks, BMRs, GMP documents.

Conocimientos

GMP compliance

Process monitoring

Documentation

Cross-functional collaboration

Educación

MSc/MTech/BTech

Descripción del empleo

Designation: Executive/Sr. Executive

Department:DS MFG

Qualification:M.Sc/M.Tech/B.Tech

Role & responsibilities

For Upstream Processing

• 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.
• Performupstream 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) andother 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.

For Downstream Processing

• Execute Downstreamprocessing 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 Downstreamprocessing 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 DSPequipment, 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), andother 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.