Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.
The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets.
Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.
JGL's full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.
Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18.
Kindly refer www.jubilantpharma.com for more information about organization.
- Reporting
- Field alert report logging and associated activity tracking
- Product Recall
- Logging and tracking of product recall related activities in coordination with customer / QP (As Quality Recall Coordinator)
- Change Control & Deviations
- Review, approval and closures of change controls, deviations, CAPA, associated trends, extensions and conducting their effectiveness check in Trackwise (As Quality SME and Quality Contact)
- SOPs
- Review and approval of departmental and other departmental SOPs
- Training & Development
- Review and approval of training plan and impart trainings as per schedule to meet cGMP requirement. To perform role of training coordinator in ComplianceWire
- Liaisoning
- To coordinate with external agency / customer for site audit / visit planning
- To coordinate with various departments for timely response of customer and regulatory audit observations
- Coordination for data collection with various departments, data compilation and conducting of Quality Metrics review (As Quality council Coordinator)
- Audits
- Planning, conducting and closure verification of Internal Quality Audits
- Batch Records
- Review of Batch records, Analytical records and approval, release or rejection of the finished drug products for distribution / sale (Usage decision in SAP) in absence of designated person
- Customer Service
- To coordinate with various customer / QP to resolve any queries or to provide required documents
- RM / PM / FG
- Review and approval of raw materials, packaging material and finished product specifications, standard test procedure and GTPs. Approval of analytical work order in SAP
- Analytical Records & Stability Data
- Review of analytical records, Stability data sheet and batch records intended for filling and compliance of documents in line with filled documents, approved ANDAs & MAs
- Annual Product Quality Review
- Review and approval of Annual Products Quality Review
- Investigations
- Review of OOS, OOT and respective investigations
- Review and approval of temperature excursion investigation report
- Risk Assessment
- Responsible for review and approval of risk assessment, control and communication
