Deputy Manager-Quality Control

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:

• Review and approval of Analytical data
• Review and approval of Lab incidents/OOCof QC and ECF.
• Review of OOS/OOT/Deviation of QC
• Review and approval of QC instruments Calibration/qualification
• Review and approval of Method validation/Method transfer/Method verification/ from QC
• Responsible for routine lab rounds/shop floor compliance
• Review and approval of Specification and method of Analysis
• Shall be responsible for review of electronic data and audit trails of chromatographic and standalone instruments.
• Shall be responsible for review and approval of customer specific order.
• Analytical support during customer and regulatory audit.
• Shall be responsible for batch release, control sample & document management.
• Trending of quality over sight observations and to propose remediation plans for the recurring audit/quality oversight observations
• QMS activities in Trackwise system and handling of documents through SAP system, as applicable
• To ensure implementation of CAPA for audits / inspection findings and ensure the effectiveness
• Responsible for QC change control evaluation.
• To review of Quality Assurance SOP’s against the practices.
• In the absence of the position holder tactical/operational responsibilities delegated to direct reports
• Responsible for carrying out any other assignment assigned by reporting manager

Education Qualification and Experience: Post Graduate of Science / Bachelors of Engineering /Doctorate with 8+ years of experience from API industry.