• 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 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
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
Participate in customer, regulatory, and internal audits including USFDA, MHRA, WHO-GMP, EDQM, and other global regulatory inspections. Provide analytical data and laboratory documentation during inspections. Ensure audi…
Skills: Regulatory Audits, Analytical Documentation, cGMP, GLP, 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…
• 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
• 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
• 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 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
• 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
• 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
Lead and maintain the site Quality Management System in compliance with cGMP, ICH, WHO, USFDA, EU GMP, and other applicable regulatory requirements. Review and approve SOPs, specifications, protocols, reports, and qualit…
Skills: Quality Management System, cGMP, ICH Guidelines, WHO Guidelines, USFDA Compliance
Monitor shop floor activities to ensure compliance with cGMP, SOPs, approved Batch Manufacturing Records (BMR), and regulatory requirements. Review Batch Manufacturing Records (BMR), logbooks, equipment records, and GMP …
Skills: cGMP Compliance, Batch Manufacturing Record Review, CAPA Implementation, Quality Risk Management, Process Validation
MISSION STATEMENT The Senior API Procurement Category Manager is the strategic commercial owner of Zentiva’s assigned Indian supplier portfolio for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSM…
Job Title: Executive – Production, Pharma Educational Qualification and Experience: M. Pharm / B. Pharm from a reputed university, having 1 to 5 years in pharmaceutical manufacturing (Preferably in Granulation , compress…
Skills: Pharmaceutical Manufacturing, Granulation, Compression, Coating, SAP
JOB Title- Executive - Production, Pharma Educational Requirement- Diploma in Pharmacy or Graduate Experience 8 to 10 years in pharmaceutical manufacturing (Preferably in Coating section) Key Accountability: Production I…
Skills: Pharmaceutical Manufacturing, Coating Process, SAP, ISO 14001, GMP
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Full-time
Posted 10d ago
~40 hrs/week
Responsibilities
Perform chemical analysis of raw materials, intermediates, and APIs using HPLC while adhering to GLP and cGMP standards. Maintain laboratory documentation, instrument calibration, and ensure compliance with CFR 21 Part 11 and data integrity protocols.
Requirements
The candidate must be able to conduct stability studies and handle OOS/OOT investigations within a QC laboratory setting. Proficiency in using LIMS and maintaining detailed instrument logbooks is required.
Full job description
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/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis.
To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures.
To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section – Head / Or QC head.
To ensure that every specification and method of analysis used of right product/material code.
To follow the instruction of Shift /Section In charge for analysis /planning.
To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation.
Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.
To record and ensure all the entries, and results are in line with current specifications and STPs.
To ensure the all column performance and column entry are maintain in column logbooks.
To maintain instruments log books properly as per analysis.
To acquire training from concerned person to update the cGMP system update technical knowledge.
To maintain reference / working standard/impurity standard usage records.
To maintain instrument history record.
Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC.
Preparation of stability protocols and stability reports.
To perform analysis of stability samples as per stability schedule
Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
Perform holding time study of intermediates and preparation of reports.
Inform and Investigate OOS results in RM/Intermediates/APIs
Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to
Maintain proper data integrity.
To ensure no spillage of lab. Chemicals / solvents
To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents.
To coordinate with store department to prior information of urgent analysis of raw material.
Related keywords
GLPHPLCCFR 21 Part 11LIMSAPIStability StudyOOSOOTcGMPData IntegrityAnalytical Method TransferCalibrationQC LaboratorySTPSOPChromatography
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/