Production Operations Specialist

4 days ago

Hyderabad Secunderabad Telangana, India beBeeProductionOperations Full time ₹ 1,04,000 - ₹ 1,30,878
Production Operations Specialist

This role is responsible for ensuring the smooth operation of production areas and equipment.

  • Cleanliness and Maintenance: Monitor cleaning of area drains, update related documentation and ensure compliance with GMP standards.
  • Room and Equipment Status: Update room and equipment status labels as per procedure.
  • Material and Equipment Readiness: Verify availability and readiness of materials and equipment required for batch processing.
  • Pre-Batch Preparations: Prepare production areas and equipment prior to batch activities.
  • Batch Execution and Monitoring: Execute and monitor batch processes, ensuring compliance with GMP standards.
  • Sampling and Labeling: Handle sampling and labeling of in-process and final product samples.
  • Incident Reporting: Report incidents and abnormalities to the Shift In-Charge promptly.
  • Column Packing and Evaluation: Assist in column packing, unpacking, and evaluation activities.
Chromatography and Resin Handling Expertise

As a Production Operations Specialist, you will be responsible for performing monitoring and maintenance of chromatography columns and resins throughout the process lifecycle.

  • Resin Maintenance: Perform monitoring and maintenance of chromatography columns and resins.
Documentation Management Skills

You will review new and revised SOPs and protocols for practical feasibility and update logbooks, batch manufacturing records (BMRs), and online annexures accurately and in a timely manner.

  • SOP Review: Review new and revised SOPs and protocols for practical feasibility.
  • Logbook Updates: Update logbooks, batch manufacturing records (BMRs), and online annexures accurately and in a timely manner.
Equipment Operation Expertise

As a Production Operations Specialist, you will operate key production equipment including but not limited to AKTA Process and AKTA Pilot Purification Systems, TFF Systems, Peristaltic Pumps, LAFU and Filter Integrity Tester, pH Meter, Conductivity Meter, Mixing Systems and Heat Exchangers, Walk-In Cold Rooms and Freezer Rooms.

  • Equipment Operation: Operate key production equipment.
Training and Compliance Responsibilities

Attend training sessions on GMP, SOPs, and other regulatory procedures as per schedule.

  • Training Attendance: Attend training sessions on GMP, SOPs, and other regulatory procedures as per schedule.
Quality Management Systems (QMS) Expertise

Initiate breakdown requests and coordinate maintenance, initiate and support Change Request Notes (CRNs), incident reports, investigations, and CAPAs in alignment with QMS standards.

  • Breakdown Requests: Initiate breakdown requests and coordinate maintenance.
  • Change Request Support: Initiate and support Change Request Notes (CRNs), incident reports, investigations, and CAPAs in alignment with QMS standards.

The ideal candidate will possess excellent communication and organizational skills, be able to work effectively in a team environment, and demonstrate a commitment to quality and safety. If you are a detail-oriented professional with a passion for improving processes, we encourage you to apply for this exciting opportunity.

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