Execute batch manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor API manufacturing processes, including reaction, filtration, centrifugation, dryi…
Skills: Batch Manufacturing, API Manufacturing, cGMP, GDP, Data Integrity
• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermed…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermed…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
Review and approve batch manufacturing records (BMR), batch packaging records (BPR), logbooks, and analytical reports. Perform line clearance activities before and after manufacturing operations. Monitor and verify compl…
Skills: cGMP, GDP, Data Integrity, SOP Review, Line Clearance
Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process conditions for batch as per …
Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process conditions for batch as per …
Skills: Production Monitoring, cGMP Compliance, Documentation, Safety Management, Equipment Calibration
Receive raw materials, verify quantity and documentation against Purchase Orders and Goods Receipt Notes (GRN). Ensure proper identification, labeling, quarantine, approved, and rejected status of materials. Maintain mat…
Skills: Inventory Management, SAP/ERP, FIFO/FEFO, GMP, GDP
• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermed…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermed…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
Perform analysis of raw materials, intermediates, APIs, stability samples, and finished products using HPLC. Operate, calibrate, and maintain HPLC systems as per SOPs. Prepare mobile phases, reagents, standard solutions,…
Monitor critical production KPIs such as batch cycle time, yield, OEE, right-first-time, and schedule adherence. Lead root cause analysis and implementation of corrective and preventive actions. People Leadership Ensure …
Skills: Production Monitoring, Root Cause Analysis, People Leadership, cGMP Compliance, Regulatory Compliance
Plan and execute daily, weekly, and monthly API production activities as per the production schedule. Ensure adherence to cGMP, SOPs, BMR/BPR, and regulatory requirements. Monitor manufacturing processes, batch yields, c…
Skills: API Production, cGMP Compliance, Production Planning, Team Supervision, CAPA Implementation
Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process conditions for batch as per …
Skills: Production Monitoring, cGMP Compliance, Documentation, Equipment Calibration, Safety Management
• Review of analytical data of scale up and validation batches, commercial batches of finished products and also of raw materials, packing material, in process, intermediate, hold time study, stability study and working …
Skills: Analytical Data Review, Quality Control, SAP, LIMS, Regulatory Compliance
• To ensure the timely sampling and testing of purified water, Process and finish product samples. • To ensure timely regeneration and maintenance of the Culture • To ensure the media preparation as per the analysis plan…
• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermed…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
• To ensure cGMP compliance at manufacturing facility [PR, PR (SRP), Quality units, HR, EHS, ST, EG departments] as well as to ensure the whether they are following the standard procedures. • Responsible to ensure online…
Skills: cGMP Compliance, Data Integrity, Line Clearance, Quality Assurance, CAPA
Principal Tasks &Responsibilities • Work allocation for sampling , analysis of finish products, returned goods and review of analytical data generated through LIMS / modules and report to Section Head / or HOD - QC. • Re…
Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process conditions for batch as per …
Skills: Production Monitoring, cGMP Compliance, Documentation, Equipment Calibration, Safety Management
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and approved SOPs. Monitor critical process parameters and ensure compliance with process specifications. Operate and supervise reactors, cent…
Skills: API Manufacturing, BMR Execution, Equipment Operation, cGMP Compliance, GDP
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Full-time
Posted 10d ago
~40 hrs/week
Responsibilities
Execute batch manufacturing activities for API production following approved records and SOPs. Monitor processes including reaction, filtration, and packing while ensuring strict adherence to GMP and quality standards.
Requirements
Experience in operating API manufacturing equipment and maintaining accurate GMP documentation. Ability to handle deviations, implement CAPAs, and coordinate with warehouse and shift teams.
Full job description
Execute batch manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor API manufacturing processes, including reaction, filtration, centrifugation, drying, blending, micronization, and packing. Ensure adherence to process parameters and promptly escalate any deviations or abnormalities. Coordinate with shift teams to ensure smooth production operations and optimum equipment utilization. Verify material availability and coordinate with warehouse personnel for timely issuance and reconciliation. Ensure accurate and timely completion of BMRs, logbooks, equipment usage records, and other GMP documents. Comply with cGMP, GDP, data integrity requirements, and site quality standards. Support investigations related to deviations, incidents, OOS/OOT, and implement CAPAs. Follow approved SOPs and ensure adherence to regulatory requirements.
Related keywords
API ManufacturingBatch Manufacturing RecordBMRSOPcGMPGDPData IntegrityFiltrationCentrifugationMicronizationOOSOOTCAPAQuality StandardsProduction Planning
Founded by Shri I.A. Modi, Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the State of Gujarat. Over the last seven decades, the company has been developing and manufacturing pharmaceutical products in India and selling and distributing these in over hundred other countries around the world.
Focused strongly on Innovation and Research, the company is present in more than forty-five therapeutic areas spread across twelve specialities, including cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals.
At Cadila Pharmaceuticals, Research and Development is at the core of all its initiatives, be it Biotechnology, APIs, Formulations, Plant Tissue Culture or Phytochemistry.
More than 300 scientists in its various Research and Development setups reinforce the competitiveness of research in the therapeutic areas which have high unmet medical needs.
Cadila Pharmaceuticals Excellence in manufacturing facilities is central to Cadila Pharmaceuticals. The company’s formulations manufacturing plant at Dholka near Ahmedabad, Gujarat is spread over hundred acres of land. This state-of-the- art facility is not only impressive in size, but is also USFDA approved.
The second formulations manufacturing facility is located at Samba in Jammu and Kashmir. The facility meets most of the stringent quality standards across the globe to produce tablets, capsules, soft and hard gelatin capsules, liquids and orals.
Two Active Pharmaceutical Ingredient (API) manufacturing units at Ankleshwar, Gujarat manufacture a wide range of APIs and intermediates including many USFDA-certified products.
The company has strong foothold in the African continent through its formulation manufacturing facility at Addis Ababa in Ethiopia.
For more information visit: https://www.cadilapharma.com/
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