Dy Manager-Quality Assurance

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. Key Responsibilities Includes: Quality Management system:

• Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA related to Plant-5 and closure of the same before the product release.
• Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities of Plant-5 within the due date.

Manufacturing Compliances:

• Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident.
• Shall be responsible for performing unplanned audit on shop floor.

Annual Product Quality Review’s:

• Preparation of PPQR and APR of the products manufactured in Plant-5.

SOP Compliance:

• Preparation of Quality Assurance SOPs and review of SOPs related to Plant-5.

Risk Assessment :

• Preparation and review of Risk Assessment Reports related to Plant-5.

Product Quality Metrics:

• Preparation of Plant Metrics, Product Metrics for Plant-5 products and to achieve established Quality metrics.

Documentation Archival:

• Archival of change control and other related documents.

Skills Required: Functional Skills:

• Good Knowledge of Regulatory Guidelines like USFDA, MHRA ANVISA, TGA, MCC etc.
• Knowledge of cGMP & Quality systems.

Behavioral Skills:

• Having good analytical, communication & interpersonal skills

Education & Experience:

• M.Sc., Education Qualification
• 10-12 years of experience in Pharma industry