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AM - Quality Assurance

Location Nanjangud, India
Posted 09-September-2021
Description

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 its 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. RD 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.

JGLs 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.

JD

Accountabilities Scope of work

Accident/Incident Investigation

Investigation of Out Of Specification laboratory results, Deviations/incidents and documentation of such investigation including action plan.

SOP Preparation and Implementation

Preparation and implementation of SOPs to meet cGMP requirements.
Implementation of Corporate SOPs at sites.

Documentation

To approve the documents related to qualification and validation activity, summaries of the different validation activities.
Preparation and maintenance of request documentation of review, issue, archival and of set Quality Assurance procedure.

Risk Management

Evaluation of risk management related to the product synthesis at sites.

Liaising

To co-ordinate with out-side parties and with intradepartmental persons for smooth activities.

System Upgradation

To upgrade the Quality system as per current regulatory/customer requirements.

Planning

Preparation of validation master plan, site master plan.

Audits

To co-ordinate for internal and external audits related to facilities and systems.

Test Method Development

Employee Training and Development

Ensure training of personnel as per scheduled activity.
To provide cGMP/Regulatory training to all concern at site.

Redressal of queries

Regular involvement in new projects and responses for all queries related to Quality Assurance.

 
Awards & Accolades for MyTechLogy
Winner of
REDHERRING
Top 100 Asia
Finalist at SiTF Awards 2014 under the category Best Social & Community Product
Finalist at HR Vendor of the Year 2015 Awards under the category Best Learning Management System
Finalist at HR Vendor of the Year 2015 Awards under the category Best Talent Management Software
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