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 valuable 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

Perks:
Food provided
Health insurance
Leave encashment
Provident Fund

Work Location: In person

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