Job title: Officer-Quality Control (OSD Regulatory)
Company: Jubilant Pharmova
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 Radiop
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 for more information about organization 1. DETAILS OF THE JOB Designation & Job : Officer Level : 7 Business Unit : Dosage Forms & API Function : Quality Control Country : India Work Location : Roorkee Reporting Manager : Assistant Manager – QC Manager’s Manager : Senior Manager – QC Matrix Manager : – Team Size : 07-08 Direct Reportees : NA 2. PURPOSE OF THE JOB Job Context: Sampling and Analysis of Packing material, raw material, semi – finished drugs, finished drugs by ensuring compliance and also to maintain the instruments in calibrated state. Challenges: Calibration and Preventive Maintenance of instruments, Preparation of reference / working standards, method development / validation, maintaining cGMP and other compliances in area, correct recording and measuring of results. 3. SCOPE & SIZE OF THE ROLE: (Please indicate key metrics defining the & scope of the role) Revenue / Operating Budget : Geographical Responsibilities : (Global/International/Country/Area within country) Roorkee Plant Area of Impact : (Dept. Location / Function or Business / Organisation) Production, Warehouse, Quality Assurance, Technical Services 4. KEY ACCOUNTABILITIES Accountabilities Scope of work Analysis Analysis of Inprocess samples, finish products, stability samples, raw materials and swab samples Calibration Calibration of equipment and instruments Documentation Documentation as per cGMP requirement SAP Responsible for data entry in SAP Sampling Receipt and storage of samples in QC Lab Safety To ensure safety precautions in QC Lab Analytical Method Transfer Carry out analytical method transfer, method validation as per approved protocol Compliance To ensure the GLP compliance in QC Lab Housekeeping Maintenance of good housekeeping in QC Lab 5. KEY INTERFACES External Interfaces Internal Interfaces Auditors Production Warehouse Quality Assurance Technical Services 6. EDUCATION & EXPERIENCE Education Qualification (Highest) with target Institution(s) : B.Pharm / B.Sc. (Chemistry) Desired Certifications : – Experience Range : 3-6 years No. of years post Highest Qualification : 3-6 years Desirable Experience : 3-6 years of experience in Quality Control department and handle all RM/PM analysis and related instruments 7. SKILLS REQUIRED Skills Description Proficiency Level () Functional Skills : Operation of all packing material, raw material analyzing Instrument, Kensa, Bursting strength, IR, DSC. Review of Pharmacopoeia & exposure to ERP system preferably BaaN Functional Expert Behavioral Skills : Attention to detail Data collection, management and analysis Problem analysis and problem solving Customer service orientation Willingness to learn and adapt to changes Working Knowledge General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concepts in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.
Expected salary:
Location: Roorkee, Uttarakhand
Job date: Thu, 23 Jun 2022 22:44:22 GMT
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