Company Introduction
Zenotech is a pharmaceutical manufacturing organization engaged in regulated injectable formulations with established quality systems and compliance-driven infrastructure.
Core Responsibilities
- Review batch manufacturing records against approved master documents using QMS checklists and controlled formats.
- Verify laboratory notebooks, chromatograms, and raw data files generated from HPLC and related analytical instruments.
- Inspect change control forms, impact assessment sheets, and closure records maintained within the electronic QMS.
- Examine deviation investigation files, root cause worksheets, and effectiveness verification reports stored in compliance archives.
- Assess stability study protocols, pull schedules, and compiled trend summaries for injectable products.
- Approve validation reports covering cleaning, sterilization, and aseptic media fill studies.
Skills & Technical Exposure
- Electronic Quality Management System platforms and controlled document repositories.
- Batch Manufacturing Records, Master Formula Records, and validation dossiers.
- HPLC systems, data acquisition software, and audit trail review tools.
- Stability chambers, temperature mapping reports, and monitoring logs.
- Regulatory guidelines including cGMP, WHO-GMP, and injectable compliance manuals.
Experience Context
- Work is performed within injectable manufacturing plants and associated quality review offices.
- Daily handling involves multiple commercial batches, validation packages, and stability sample sets.
- Absence of this role results in incomplete batch disposition and regulatory non-acceptance.
How to Apply
hr1@zenotech.co.in
