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 Responsibility\'s Include: Intermediate/Clean room/SRP: Producing Intermediates/API/Solvent Recovery according to pre-approved instructions and to record the same in respective BPR/documents. To perform the cleaning activity as per the procedure and to record the same in respective BCR/documents. Maintaining the Intermediate/Pharma/SRP and equipment clean and well appropriately disinfected. Control the process & plant operations according to the BPR, SOP, Check-lists, Instructions, etc., Maintain the critical process parameters (CPP) to ensure \'right first time (RFT)\' Quality & yield. Execute the operations to prevent any mis-operations or losses during the execution of processes. Identify the abnormalities exist / happen in the plant with respect to equipment, material, men & process safety, environment impacts, etc., and take actions to implement counter-measures in coordination with support functions like Engineering, EHS, TSD / TT, etc., Maintain 5S in the plant & upkeep. Track the quality trends in reference to the operating parameters of the processes to effectively produce quality products To ensure that the respective equipment is calibrated Maintaining the respective equipment /Area in clean condition. Online updating of equipment status boards w.r.t to equipment status. Identifying /Labelling of accessories (e.g. Scoop /Scrapper/Hose pipe/Filter bags/ AHU filters / micron filter cartridges) and storing the same in designated place. Identify the abnormalities associated risk and objectives by cross verifying the interlocks in equipment. To ensure the availability of utilities and to maintain the same by requesting utility department whenever required. Participate in execution of improvement projects like Kaizen / Sankalp, cost-reduction, capacity enhancement, quality improvement & operations improvement. Prevent speed & change-over losses to maintain OEE / OPE of the plant to the optimum level Material Handling: Receiving the raw material from the stores and storage of raw materials in the designated place. Identification and storage of intermediates/ API\'s in the designated place. Maintaining the RM/ intermediate/ rejected material storage area clean and when appropriate disinfected. To ensure that the intermediate retest verification and seeding material availability as per the requirements. To ensure the availability of labels and to cross verify the quantity and material against the picklist before receiving. To return the raw material which is not used as per the SOP. To purchase the new accessories and to provide numbering for the same as per respective SOP. To indent, receive, issue the required labels and packing materials as per the production requirements and maintain the availability. Documentation: To indent, receive and issue therequired documents with in timeline according to pre-approved instructions . To ensure that documents being recorded contemporaneously. To ensure the records are updating contemporaneously and to facilitate the required documents. To ensure the availability of calibration documents where ever required. To ensure the online entries of status board, log books and daily updating documents. To ensure the accessories are properly maintained/ destructed as per the respective SOP and it is properly documented. To address the error/deviation through proper cGMP documents and to co-ordinate colleagues for closure of the respective formats. To submit the completed documents with in the timeline as per respective SOP. Prevent failures and participate in deriving effective CAPA to prevent failures. Ensure internal & external audit compliance with respect tocGMP, EHS & material reconciliation, etc., Prevent cross-contamination, extraneous / metallic contamination in the products produced in the plant by following appropriate procedures as per SOP. Safety, health and environment: On line monitoring of the environment conditions in process area. Functional Skills; Handling of production equipment Documentation capabilities like filling of BMR / BPR etc. Knowledge of basic CGMP. Behavioral Skills: Critical thinker Problem solving attitude Attention to details EDUCATION & EXPERIENCE: Degree in Science / Graduate Engineers - Chemical/Diploma in Chemical Engineering (Chemistry/Chemical/PCM/Bio-Chemistry) 4- 6 years.

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