Mahaboob Mohinuddin Shaik

Job responsibilities at Eugia Pharma Specialties Ltd.

Preparation of CSV schedules yearly, and addendum schedules for newly qualified systems pertaining to GxP systems, 21CFR part 11 process Equipment's.

Performed monthly-wise data backup, data restoration, audit trial, periodic time verification for process equipment, and weekly verifications of filter integrity machines as per the defined schedules.

System administrator for process equipment systems. 21CFR part11 User’s access (privileges).

Review of computerized system validation protocols and summary reports, IQ, OQ, etc. For process equipment.

Preparation of high-level risk assessment (HLRA) and recipes creation of process equipment, as per user/batch requirements.

Maintaining the CSV inventory list, 21 CFR part 11 equipment, for process equipment.

Handling of QMS for all the computerized systems and engineer-related change controls, PNC, CAPAs.

Review of calibration, PMP yearly schedules, and addendum schedules.

Review of calibration certificates, BMS reports.

Review the work orders related to engineering departments and CSV.

Review of Quarterly trends review for Calibration, PMP in engineering departments.

Troubleshooting and periodic calibrations of Analytical Instruments online and offline, such as pH conductivity, turbidity, dissolved oxygen, and TOC analyzers.
Process control instruments like flow meter, level transmitter, load cell, temperature transmitters, pressure transmitters, pressure gauge, and magnehelic gauge, mass flow controllers, and data loggers.
Performed batch-to-batch calibration/verification during batch start-up. Verification and validation of process equipment's temperature mapping. Supporting validation activities, temperature mappings for equipment such as autoclaves, cold rooms, incubators, refrigerators, and room qualification.
Preparation of monthly calibration planner and closing deviations, CAPA, etc.
Coordinating with vendor for external instrument calibration and troubleshooting.
Preparing calibration checklist and monitoring external calibration certificates. Which we are receiving from vendors after calibrations. Coordination with all concerned departments for periodic calibration and documentation requirements. Working on SAP operations such as complaint closing, spare instruments monitoring.

Installation of various instruments like flow meters, level transmitters, pressure transmitters, and water quality instruments like pH (Jenco). Conductivity (Jenco). Turbidity (Scientific global). Dissolved oxygen (WWT) and chlorine analyzer (Hf scientific and orlab).

Planning and coordinating with the contractors and commissioning team for timely completion of all activities with all necessary cooperation.

Instrument calibration and maintenance of field instruments.

Resolve the contractor's raised queries with the technical support group.

Handling of Final Installation of Instruments and Proposing AMC's.

Testing of instruments in the commissioning stage.

Preparation of FSR reports and quotations, test certificates.