SENIOR SCIENTIFIC OFFICER

☞ Panacea Biotec

Visualizza: 94

Giorno di aggiornamento: 15-05-2024

Località: Mohali Punjab

Categoria: R & D IT - Software

Industria: Pharmaceutical Manufacturing

Posizione: Mid-Senior level

Tipo di lavoro: Full-time

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Contenuto del lavoro

  • Hands on Knowledge of line clearance at shop floor, Weighing Balance operation,

Filter Integrity operation, Sterilization by Autoclave, Dry Heat sterilization and

Filtration, gowning qualification etc.

  • Ensure online documentation as per good documentation process.
  • Experience on Inspection and verification of analytical activities at shopfloor
  • Verification of Packing and Dispatch activity for Final ARM/Bulk, product/

Intermediate Product Destruction, Defrosting and Preventive maintenance of deep

freezer.

  • Review of Batch Production records, Analytical files, product campaign change

over activity of product (s) manufactured,

  • Proficient in analytical procedures and analytical method validations
  • Monitoring of ongoing Validation activity on shop floor.
  • Issuance of Cell Bank, Reference standards, Retention sample and Stability

Sample.

  • Proficient knowledge about analytical techniques eg HPLC, Cell Culture based

testing, Microbiological testing, ELISA, Endotoxin etc.

  • Ability to analyze the analytical data w.r.t. production process step
  • Review of analytical data, capability to analyze the raw data of HPLC, GC,

spectrophotometer etc.

  • Right allocation of manpower in shift working and monitoring of assigned task with

optimum output

  • Ensure Quality and quantity of consumables, Solutions with adequate usage &

timely delivery to different manufacturing processes.

  • Right & Timely Documentation including SOPs, Change Controls, Deviations,

Incidents, CAPA, Risk Assessments, in preview of PQS in view to regulatory

guidelines & expectations.

  • Ensure zero non- compliance & zero data integrity in documentation.
  • Ensure regular maintenance of all equipment`s of production by engineering to

achieve zero-breakdown.

  • Coordination with intra departmental activities in compliance to support/execution.
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Scadenza: 14-06-2024

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