Job 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 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 Include: Responsible to ensure and maintain standardized methods for software validations and ensure effective implementation and follow as part of the Corporate Quality Control by direct interaction with all departments with respect to Computer System Validation (CSV). Responsible to assist site personnel/management in developing protocols, test cases, validation packages, etc. for validations of computerized system Well versed with Legal & Statutory requirement for HT/LT Elect. System with desired Protection & Safety Standards applicable for Chemical & Power Plants. Formulation and Execution of Maintenance Cost reduction schemes. To co-ordinate with Government bodies, various contractors, consultants. Responsible to review process software validation plans, software requirements, validation protocols, test cases, IQ/OQ/PQ but not limited to, such as equipment\'s & instruments, software\'s etc., design and develop a system for tracking and cataloguing in house software and the respective validations. Maximum availability & reliability of electrical system for process Operation & Control with desired safety of Man, Machine & Environment. (Increase MTBF and reduce MTTR) Optimization of Departmental Inventory, budgetary planning and reduce the R&M cost. Ensure there are no operational compliance-related issues within their aligned area by providing independent assurance and oversight of processes and controls Responsible to identify, communicate and manage compliance risks, breaches and issues, and monitor corrective action to mitigate the risk through risk assessment Responsible to lead CSV/ IT Compliance related activity of JGL\'s Nanjangud, Responsible to lead, coach and manage CSV/ IT Compliance team Have practiced modern Electrical maintenance techniques for better efficiency of the electrical installations. Responsible for new initiatives identified and delivering in accordance with business and regulatory requirement Exposure to TPM, WCM, MAXIMO, ISO certification systems is desired. To conduct internal reviews and compliance at site. To assess and improve the cGMP practices and procedures To ensure the IT security policies are in line with the established guideline Shall be responsible for reviewing audit observation and ensuring implementation of CAPA To ensure that complete utilities are operated at their maximum efficiency. Effective supervision of operation of DG sets, transformer, HT & LT Substation and air conditioning system. Exposure to TPM, WCM, MAXIMO, ISO certification systems is desired. Planning of preventive maintenance of all the electrical installations. Liaison with KSEB and related agencies for legal and statutory compliance. Development of In-house resources & skill to reduce dependability on OEM. Formulation and Execution of Natural Resource Conservation Knowledge & experience in projects and maintenance of HT & LT Electrical Systems like Alternators, Transformers, Motors, and Protection relays etc. Experience & Qualification: Must have 17+ Years of experience in the related field and must be a qualified BSc/MSc/BE degree holder.

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