Perform analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples using HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, Dissolution, and other laboratory …
Skills: HPLC, GC, UV-Visible Spectrophotometry, FTIR, Karl Fischer
Execute API manufacturing activities as per approved BMR, SOPs, and production plans. Supervise shift operations involving reactors, centrifuges, dryers, filters, and other process equipment. Ensure compliance with cGMP,…
Skills: API Manufacturing, cGMP Compliance, GDP, EHS, Data Integrity
Manage day-to-day operations of the QC laboratory, ensuring adherence to cGMP, GLP, and regulatory requirements. Review and approve analytical data, laboratory records, specifications, Certificates of Analysis (CoA), and…
Implement and monitor EHS policies, procedures, and safe work practices across the plant. Ensure compliance with applicable statutory requirements, including Factories Act, Pollution Control Board regulations, Hazardous …
Perform and review analysis of raw materials, intermediates, finished products, in-process, stability, water, and cleaning validation samples as per approved specifications and test methods. Operate, troubleshoot, and ma…
Skills: HPLC, GC, UV-Visible Spectrophotometry, FTIR, Karl Fischer Titration
Execute API manufacturing activities as per approved BMR, SOPs, and production plans. Supervise shift operations involving reactors, centrifuges, dryers, filters, and other process equipment. Ensure compliance with cGMP,…
Skills: API Manufacturing, cGMP, GDP, EHS, Data Integrity
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
Ensure compliance with cGMP, GDP, GLP, Data Integrity (ALCOA+), SOPs, and regulatory guidelines. Perform shop floor QA activities, including line clearance, equipment clearance, area clearance, and in-process verificatio…
Skills: cGMP, GDP, GLP, Data Integrity, Line Clearance
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor process equipment …
Skills: API Manufacturing, cGMP Compliance, Good Documentation Practices, Process Equipment Operation, Line Clearance
Execute batch manufacturing activities as per Batch Manufacturing Record (BMR), SOPs, and approved process parameters. Operate and monitor reactors, centrifuges, dryers, filters, blenders, and other process equipment. En…
Skills: Batch Manufacturing, cGMP, EHS, Data Integrity, Equipment Operation
Perform analysis of raw materials, intermediates, finished products, in-process samples, solvents, and stability samples as per approved specifications and SOPs. Operate analytical instruments such as HPLC, GC, UV-Visibl…
• 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
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 …
Perform chemical analysis of raw materials, intermediates, APIs, stability samples, and finished products using approved analytical methods. Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectr…
Skills: Chemical Analysis, HPLC, GC, UV-Visible Spectrophotometry, FTIR
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 Management, cGMP Compliance, Documentation, Safety Management, Quality Control
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor process equipment …
Skills: API Manufacturing, cGMP, Good Documentation Practices, Process Equipment Operation, Line Clearance
Documentation: • To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice. • Ensure that all documents / records required for Regulatory Compliance are main…
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and approved Standard Operating Procedures (SOPs). Operate and monitor reactors, centrifuges, dryers, filters, blenders, micronizers, and othe…
Skills: API Manufacturing, cGMP, GDP, Data Integrity, Equipment Operation
Process Development: • Conduct laboratory experiments & trials to modify processes develop shorter processes to reduce present cost. • Send sample to QC of studied experiment. • Contact QC dept. to solicit support & foll…
Skills: Process Development, Laboratory Experiments, Sample Analysis, Data Generation, Vendor Qualification
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
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Full-time
Posted 6d ago
~40 hrs/week
Responsibilities
Perform chemical analysis of raw materials, intermediates, and finished products using various laboratory instruments. Ensure strict compliance with SOPs, GLP, and data integrity principles while documenting results and supporting method validations.
Requirements
The candidate must be proficient in operating analytical instruments like HPLC and GC and managing OOS/OOT investigations. Experience in a regulated laboratory environment following ALCOA+ and GLP standards is required.
Full job description
Perform analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples using HPLC, GC, UV-Visible Spectrophotometer, FTIR, Karl Fischer, Dissolution, and other laboratory instruments. Execute routine chemical analysis as per approved specifications, pharmacopoeias, test methods, and Standard Operating Procedures (SOPs). Ensure timely documentation of analytical data in laboratory notebooks, worksheets, and electronic systems in compliance with ALCOA+ and Data Integrity principles. Prepare, standardize, and maintain volumetric solutions, reagents, mobile phases, and analytical standards. Perform calibration, verification, and routine maintenance of laboratory instruments. Report Out of Specification (OOS), Out of Trend (OOT), deviations, and laboratory incidents to the reporting manager and support investigations. Review chromatograms and analytical data for accuracy and compliance before reporting results. Support analytical method validation, method verification, method transfer, and cleaning validation studies. Maintain laboratory housekeeping, safety, and Good Laboratory Practices (GLP). Ensure proper storage, handling, and disposal of laboratory chemicals, standards, and solvents. Participate in internal audits, customer audits, and regulatory inspections. Coordinate with Production, QA, Warehouse, and Engineering departments for sample management and testing activities. Follow EHS guidelines and promote a safe laboratory environment. Contribute to continuous improvement initiatives for laboratory efficiency and compliance.
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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