Executive/Sr Executive

1 day ago


Hyderabad, Telangana, India Sekhmet Pharmaventures Full time US$ 90,000 - US$ 1,20,000 per year

Role & responsibilities

Key Responsibilities

  • Execute and monitor routine API production operations in a GMP environment, adhering to SOPs, batch records, and batch release criteria.
  • Participate in process characterization, optimization, and scale-up activities for new or existing API manufacturing campaigns.
  • Collect, review, and handover plant data (WTNs, DPIs, process parameters, yields, impurity profiles) for DQ, IQ, OQ, PQ documentation.
  • Support equipment preparation, cleaning, maintenance, and calibration activities; ensure equipment is qualified and logged.
  • Drive continuous improvement by identifying bottlenecks, variabilities, and deviations; implement corrective and preventive actions (CAPA).
  • Investigate manufacturing deviations, non-conformances, and product quality issues; support root-cause analysis and issue resolution.
  • Ensure compliance with EHS, quality systems, and regulatory requirements; participate in internal and external audits.
  • Collaborate with Quality Assurance, Validation, Process Development, and Supply Chain to ensure on-time delivery of API, documentation, and change controls.
  • Maintain accurate and timely batch records, change controls, and deviation reports.
  • Participate in risk assessments, Process Hazard Analysis (PHA), and process safety initiatives.
  • Train and mentor junior operators; support shift coverage as needed.

Qualifications

  • Bachelors degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
  • 2–5 years of hands-on API production experience in a regulated (GxP) pharmaceutical environment.
  • Familiarity with cGMP, regulatory expectations (FDA, EMA, ICH guidelines), and batch release processes.
  • Experience with fermentation/biocatalysis or chemical synthesis of APIs is a plus, depending on site.


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