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, Quality Assurance
• 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…
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control unit operations such as charging, reaction, filtration, centrifugation, drying, milling, blending, and packing. …
Skills: API Manufacturing, Batch Manufacturing Records, SOP Compliance, Unit Operations, cGMP
Principal task and responsibilities: Support in Master Data Management and Training to employees. To perform the CSV related to computerized systems across the sites &its compliance. IT Compliance for computerized system…
Skills: Master Data Management, CSV, IT Compliance, GMP, Change Control
• 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
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…
• 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
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control unit operations such as charging, reaction, filtration, centrifugation, drying, milling, blending, and packing. …
Skills: API Manufacturing, Batch Manufacturing Records, SOP Compliance, Unit Operations, cGMP
• To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of work data sheet / protocols. • To work as Analyst and maintain the CFR 21 part -11 compliance by followin…
• 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…
The General Manager – Operational Excellence & Plant Head is responsible for leading the overall operations of the API manufacturing facility while driving continuous improvement initiatives to achieve world-class operat…
Skills: Plant Leadership, Operational Excellence, Lean Manufacturing, Six Sigma, TPM
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, Equipment Operation, cGMP Compliance, Good Documentation Practices, Process Monitoring
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
• To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of work data sheet / protocols. • To work as Analyst and maintain the CFR 21 part -11 compliance by followin…
Skills: GLP, GMP, Wet Analysis, CFR 21 Part 11, LIMS
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
Perform routine analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples. Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer,…
Skills: HPLC, GC, UV-Visible Spectrophotometry, FTIR, Karl Fischer
erform analysis of raw materials, packing materials, in-process samples, intermediates, finished products, stability samples, and utilities as per approved specifications and test methods. Operate and maintain analytical…
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…
Skills: HPLC Analysis, GLP Compliance, CFR 21 Part 11, LIMS, Stability Study
Position: Assistant Manager – Store (API) Department: Stores & Warehouse Location: API Manufacturing Plant Ankleshwar Reports To: Assistant General Manager – Stores Job Purpose To manage API warehouse operations, ensurin…
Review Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), logbooks, and other GMP documents for completeness, accuracy, and compliance. Ensure timely review and disposition of manufacturing records to supp…
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Full-time
Posted 8h ago
~40 hrs/week
Responsibilities
The Officer is responsible for ensuring compliance with regulatory guidelines and performing shop floor QA activities such as line and equipment clearance. They also review quality documentation and support analytical testing and validation processes.
Requirements
Candidates must have experience in quality assurance and laboratory operations within a pharmaceutical environment. Proficiency in analytical instrumentation and knowledge of international regulatory standards like USFDA and EU GMP is required.
Full job description
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 verification. Review Batch Manufacturing Records (BMR), logbooks, analytical records, and quality documents for completeness and accuracy. Perform or support analysis of raw materials, intermediates, finished products, water, stability, and cleaning validation samples (as applicable). Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, and Karl Fischer Titrator (for QC roles). Participate in investigations related to deviations, OOS, OOT, incidents, market complaints, Change Controls, and CAPA implementation. Support process validation, cleaning validation, analytical method validation, and equipment qualification activities. Maintain laboratory and QA documentation in compliance with Good Documentation Practices (GDP). Coordinate with Production, Warehouse, Engineering, and EHS to resolve quality-related issues. Ensure timely calibration and maintenance of laboratory instruments and monitoring equipment. Participate in internal audits, customer audits, and regulatory inspections (USFDA, MHRA, EU GMP, WHO GMP). Monitor environmental and GMP compliance within manufacturing and laboratory areas. Maintain quality records, registers, and reports for management review.
Related keywords
cGMPGDPGLPData IntegrityALCOA+SOPQuality AssuranceBMRHPLCGCUV-Visible SpectrophotometerFTIRKarl Fischer TitratorOOSOOTChange Control
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/