
Executive/Sr Executive
1 day ago
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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