Job Title: GMP Downstream department
Department: Downstream department
Experience: 10+ Years
Industry: Pharmaceutical Manufacturing
Location: Karkapatla, Telangana
- Experienced in GMP Downstream Manufacturing operations with 10 years of experience in pharmaceutical/biopharmaceutical production environments.
- Responsible for executing downstream processing activities as per cGMP guidelines, SOPs, BMR/BPR, and approved manufacturing procedures.
- Hands-on experience in downstream purification operations including chromatography, ultrafiltration/diafiltration (UF/DF), filtration, buffer preparation, product recovery, and intermediate handling.
- Operate and monitor downstream processing equipment such as chromatography systems, TFF systems, filtration assemblies, and process skids.
- Ensure process parameters are maintained within defined limits and support successful completion of manufacturing batches.
- Perform GMP documentation activities including batch records, equipment logbooks, cleaning records, process checklists, and data integrity compliance (ALCOA+).
- Review manufacturing documents for accuracy, completeness, and compliance with GMP requirements.
- Handle deviations, incidents, and process discrepancies; perform root cause analysis (RCA) and implement CAPA actions.
- Support change control activities, process improvements, validation batches, and technology transfer activities.
- Ensure compliance with regulatory guidelines including US FDA, EMA, and other regulatory requirements.
- Participate in internal audits, regulatory inspections, and customer audits by maintaining inspection readiness.
- Coordinate with Quality Assurance, Quality Control, Engineering, Warehouse, and other cross-functional teams for smooth batch execution.
- Provide technical support and training to junior operators and team members on GMP practices and process operations.
- Monitor production schedules, improve process efficiency, and support yield improvement initiatives.
- Maintain safety standards, environmental compliance, and good housekeeping practices in manufacturing areas.
- Support continuous improvement activities to reduce deviations, improve productivity, and optimize downstream processes.
Pay: ₹500,000.00 - ₹750,000.00 per year
Benefits:
- Food provided
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
