Manager-Quality Assurance

Jubilant Generics Limited

Website: jubilantgenerics.com
Job details:
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.

• RM/PM
  
  
  

Ensure receiving, storage, approval, rejection, dispensing of incoming material as per cGMP norms and defined procedures.

• Equipments
  
  
  

Ensure manufacturing of products by using qualified equipments and as per cGMP norms and defined procedures.

• Documentation
  
  
  

Responsible for Reviews and timely submission of various documents (BMR , BPR etc.) for filing.

• Annual Product Reviews
  
  
  

Ensure preparation and approval of Annual product reviews

• Master File
  
  
  

Responsible for approval of site master file

• In process
  
  
  

Ensure compliance of In process checks, sampling and daily monitoring records

• Change Control
  
  
  

Ensure timely completion of Change Control, deviations, OOS, incidents, market complaints, CAPA etc

• Validation
  
  
  

To ensure availability of approved process validation protocols, cleaning validation protocols before execution

To ensure qualification of equipment, instruments, facility, utilities before usage.

• Finished Goods
  
  
  

To ensure dispatch of products as per cGMP norms and defined procedures.

Release of finished products.

• Compliance
  
  
  

To ensure compliance to the regulatory and customer audits and respective recommendations. Click on Apply to know more.