Qc Chemist, R&D , production

R&D Process 1 to 3 Years mobile number 9100884499

Role: R&D Process Associate / Scientist

Key Responsibilities:

• Lead scale-up activities for new formulations from lab-scale to pilot and commercial production batches.
• Optimize critical process parameters (CPPs) such as mixing speed, temperature, pH, and filtration efficiency to ensure reproducible product quality.
• Troubleshoot process-related deviations, conduct root cause analysis for batch failures, and develop corrective action plans.
• Author and review process validation protocols, standard operating procedures (SOPs), and technology transfer documents.
• Collaborate with production, quality, and engineering teams to resolve manufacturing challenges and improve process robustness.
• Maintain detailed laboratory notebooks and ensure compliance with GMP, safety, and environmental guidelines.

Production (Cleanroom) 2 to 4 Years

Role: Production Officer / Executive (Cleanroom Operations)

Key Responsibilities:

• Operate, monitor, and maintain production equipment for filling, sealing, mixing, or assembly in a classified cleanroom environment (Grade A/B/C/D).
• Perform in-process quality checks including weight variation, leak testing, and visual inspection to ensure batch conformity.
• Strictly adhere to cleanroom gowning protocols, hygiene standards, and contamination control procedures.
• Monitor and record environmental parameters such as particle counts, temperature, humidity, and differential pressure.
• Maintain accurate batch manufacturing records, equipment logs, and cleaning documentation.
• Support equipment qualification, cleaning validation, and routine maintenance activities.
• Coordinate with QA and maintenance teams to resolve equipment malfunctions and minimize downtime.

QC Instrumentation (HPLC / GC) – 2 to 5 Years

Role: QC Analyst / Executive – Instrumentation

Key Responsibilities:

• Perform quantitative and qualitative analysis of raw materials, in-process samples, and finished products using HPLC and GC systems.
• Conduct tests for assay, purity, related substances, residual solvents, and dissolution as per pharmacopoeial standards (USP/EP/IP).
• Operate, calibrate, and perform routine maintenance and troubleshooting of HPLC, GC, UV-Vis, and other analytical instruments.
• Support analytical method validation, verification, and transfer activities in compliance with ICH and regulatory guidelines.
• Review and interpret chromatographic data, prepare Certificates of Analysis (COA), and ensure data integrity (ALCOA+ principles).
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results and document findings in deviation reports.
• Maintain compliance with cGMP, GLP, and SOPs; participate in internal and regulatory audits.