• 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…
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…
• 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
Execute API manufacturing batches as per Batch Manufacturing Records (BMR), SOPs, and approved process parameters. Independently handle shift production activities including charging, reaction monitoring, filtration, cen…
Skills: API Manufacturing, Batch Manufacturing Records, cGMP, GDP, Data Integrity
Execute manufacturing operations as per approved Batch Manufacturing Records (BMR), SOPs, and production plans. Supervise shift activities and ensure timely completion of production batches. Handle chemical reactions, cr…
Skills: Manufacturing Operations, BMR Execution, Chemical Reactions, Crystallization, Filtration
Perform shop floor QA activities to ensure compliance with cGMP, SOPs, and approved manufacturing procedures. Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks, and other GMP documents for…
Skills: Quality Assurance, cGMP Compliance, Batch Record Review, Line Clearance, CAPA
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 Environmental Clearance (EC), Consent to Operate (CTO), Consent to Establish (CTE), Hazardous Waste Rules, and all applicable environmental regulations. Lead operations and performance improvement …
Skills: Environmental Compliance, Pollution Control Systems, Process Safety Management, Regulatory Coordination, Waste Management
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
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
• Preparation of Certificate of Analysis (COA) according to released activity completed every month as per dispatched plan • Prepare inspection plan as per specification in SAP. • Prepare COA as per Specification/RA and …
Skills: SAP, Certificate of Analysis Preparation, cGMP Compliance, Quality Control Coordination, Batch Record Review
Production : • To verify raw material/ packing materials as per BPR/documents at work place with coordination of warehouse. • To coordinate with engineering departments for breakdown & preventive maintenance to avoid any…
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, Quality Control
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 …
Safety : • Assist to collect safety information. • Maintain the record of MSDS. • Support for the safety activities to colleagues. • Issue of PPE to plants as per requirement. Maintain the consumption records as per SOP,…
• 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,…
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
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Full-time
Posted 10d ago
~40 hrs/week
Responsibilities
Oversee the daily operations of the microbiology laboratory, including sampling, testing of purified water and products, and environmental monitoring. Ensure regulatory compliance through proper documentation, instrument validation, and adherence to GMP/GLP standards.
Requirements
The candidate must be proficient in microbiology lab management, aseptic conditions, and the use of LIMS. Experience in handling regulatory audits and coordinating with QA and production departments is required.
Full job description
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 planning and the effectiveness and sterility of the media to be ensured.
To ensure the aseptic condition of the microbiology testing area to be maintained
To ensure environment monitoring in the powder processing area and microbiology laboratory. Preparation of the trend for the evaluation of the environment condition of the area.
To ensure maximum utilization of laboratory Instruments.
To ensure the lab preparativeness for the regulatory and customer audits.
To ensure the timely purchase of the media ,cultures and other lab regents
To ensure the effective planning of the daily activity of the microbiology lab.
To ensure the every analysis is to be analysed as per predefined specification and method of analysis.
To report any OOS/incidents / Deviation/ discrepancy in laboratory analysis to section in charge /QC In-charge.
Ensure daily on-line entry in LIMS modules.
Ensure the calibration ,operational and validation status of the instruments in the microbiology laboratory
Ensure the timely Qualification / Validation of all instruments in microbiology laboratory.
Co-ordinate with service engineer regarding break-down and preventive maintenance of instruments.
Ensure that all documents / records required for Regulatory Compliance are maintained properly.
To ensure the analytical documents like specification, protocol, STP, are prepared as per SOP.
Ensure all issues related to completed batches are resolved and documents are transferred to QA.
To maintain instruments logbooks properly as per analysis.
To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively.
To ensure the safe disposal of the media and culture waste.
To educate and train the workmen and implement in safe handling of media, reagents, cultures, chemicals, gas cylinder and laboratory instruments to prevent the accidents.
To ensure the storage of lab. Chemicals and test samples at proper place with segregation to prevent accidents.
To coordinate with QA department for cGMP system
To coordinate with production department for planning/clubbing of analysis.
Related keywords
MicrobiologyPurified Water TestingCulture MaintenanceSterility TestingEnvironmental MonitoringLIMSOOSDeviationCalibrationValidationSTPSOPGLPGMPQuality ControlRegulatory 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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