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. 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. Material Handling: To purchase the new accessories and to provide numbering for the same as per respective SOP. To indent and maintain the utilities like nitrogen cylinder as per the pre-approved instructions. To indent, receive, issue the required labels and packing materials as per the production requirements and maintain the availability. 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. Documentation: To prepare the documents with in timeline according to pre-approved instructions and requirements. To revise the impacted documents and to provide training as per the requirements. To ensure the accessories are properly maintained/ destructed as per the respective SOP and it is properly documented. To facilitate the of calibration documents from the CFT where ever required (new facility/ new equipment incorporated). To ensure the error/deviation are closing with in the timeline and to provide required data to the investigation team/QA for closure. To provide support to CFT for trouble shooting and scale-up by providing the required data/ documents. To provide the periodic training and refreshment training to the team whenever requiredand to maintain the training reports. 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) 2- 4 years

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