• 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, Regulatory Compliance, SAP, LIMS, Data Integrity
Production : • To receive crude solvents from plants and issue recovered solvents to plants. • To check the labels of raw material, packing materials and solvents before usage. • Perform column distillation as per SDR. •…
Skills: Column Distillation, cGMP, Plant Operations, Chemical Handling, SOP Compliance
Maintenance Services : • To distribute the daily work to Engineers / Section wise in-charge as per plant & Utility job & ensure timely compliance. • To co-ordinate with electrical, instrument and Utility person for job r…
Production : • Supervision of production & maintenance activities of respective shift. • To ensure that every raw material used is of right quality (approved from QC, having reference Number) and quantity (verifying the …
Skills: Production Supervision, Maintenance Management, SAP Production Module, cGMP Compliance, Quality Control
Security : • Implementing stringent security measures for protecting man, material, information and high-value assets of the organization and conducting timely security audits. Deployment of security personnel • Promotin…
Maintenance services : • Overall responsible for compliance and maintenance of instrumental equipments/machineries at site. • Ensure preventive maintenance of the equipment’s as per checklist and instruction / Feedback f…
Skills: Preventive Maintenance, Breakdown Maintenance, Instrument Calibration, Troubleshooting, Energy Conservation
• Logging, review of Market complaints and fulfilments of other market requirements. • Logging, review of Return Goods and product recall. • Regulatory Compliances. • Responsible for customer audit and its responses. • R…
• Coordination with vendors for quotations & specifications for project. • Coordinate with Purchase team for project related procurement/job matters. • Coordinate with Finance team for payment related matters. • Coordina…
Skills: Vendor Coordination, Procurement, Project Execution, Technical Comparison, SAP
• Work allocation for sampling , analysis related to microbial testing based on requirement and plan for sampling and analysis of finish products, & (test procedures and SOPs, and review of analysis data generated throug…
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…
JOB TITLE Assistant Manager- Quality Control, Chemistry REQUIREMENTS Education / Experience Post Graduate in Science (Organic or Analytical Chemistry ) 8 to 10 years in chemical & instrumental testing laboratory with exp…
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
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…
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
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…
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
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
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…
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
• 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 3d ago
~40 hrs/week
Responsibilities
Oversee the review of analytical data for batches and raw materials while ensuring compliance with regulatory requirements and data integrity. Coordinate with QA, production, and store departments to manage analysis planning and resolve batch-related issues.
Requirements
The candidate must be proficient in GLP/GMP practices and experienced in handling OOS, OOT, and deviation investigations. Proficiency in SAP, LIMS, and CFR 21 part-11 compliance is required for maintaining electronic records.
Full job description
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 standard. Review of system audit trail and review of electronic data (Comparison of hard copy and soft copy)
To ensure the every analysis is to be performed as per predefined approved / current version of specification and method of analysis.
To ensure that all the analysis as per customer specification is done (for dispatch) as per the planning (planning to be taken as per delivery instruction) and ensure all dispatches in time with all documentation.
Monitor and Maintain records of Training, analyst validation and competency.
To ensure all records / documents are maintained in compliance to regulatory requirements.
To ensure all the entries, records and results are in line with current specifications and STPs and review and approval of reviewed certificate of analysis for raw, packing material / intermediate and APIs.
Ensure daily on-line entry in SAP and LIMS modules.
Review of outside laboratory certificate of analysis.
Ensure CFR 21 part -11 compliance and good chromatography practices followed during analysis, & review for proper of chromatographic analysis to maintain proper data integrity
Ensure that all documents / records required for Regulatory Compliance are maintained properly.
Review SOP’s for regulatory compliance and actual practice.
Ensure timey report and completion of NQI, OOS, OOT, deviation, customer / market investigation and change control.
Ensure all issues related to completed batches are resolved and documents are transferred to QA.
To revise the SOP/STP as per schedule
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 review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control department.
To co-ordinate with QA department for cGLP system
To co-ordinate with production department for on line analysis
To co-ordinate with production department for planning/clubbing of analysis.
To co-ordinate with store department to prior information of urgent analysis of raw material.
Prepare and submit reports as required.
To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.
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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