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…
• 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…
• 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
• 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…
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
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
• 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
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…
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
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
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…
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…
Perform analysis of raw materials, intermediates, finished products, in-process samples, and stability samples as per approved specifications and test methods. Operate and maintain analytical instruments such as HPLC, GC…
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
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
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
• 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 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
• 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…
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Full-time
Posted 4d ago
~40 hrs/week
Responsibilities
The officer is responsible for reviewing Batch Manufacturing and Packing Records, logbooks, and GMP documents for accuracy and compliance. They ensure the timely disposition of records to support batch release and verify material reconciliation.
Requirements
The candidate must be able to ensure documentation completeness and close gaps in manufacturing records. Proficiency in GMP standards and record verification is required.
Full job description
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 support batch release activities. Verify reconciliation of materials and ensure closure of documentation gaps
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/