Job title: Senior Executive-Production ( Regulatory-Formulation)

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. JOB DESCRIPTION 1. DETAILS OF THE JOB Designation & Job : Senior Executive Level : 9/9A Business Unit : Dosage Forms & API Function : Production – Shift In charge Country : India Work Location : Roorkee Reporting Manager : Senior Manager Manager’s Manager : AVP – Production Matrix Manager : – Team Size : Direct Reportees : 2. PURPOSE OF THE JOB Job Context: To execute the manufacturing of dosage forms through the various stages of manufacturing as per the production plan in a manner so as to ensure compliance to quality, safety & regulatory requirements & maintaining the cost within the budget. Challenges: To minimize wastage and turnaround time. Being ready with backups during breakdown, to avoid any production order loss 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) Roorkee Plant 4. KEY ACCOUNTABILITIES Accountabilities Scope of work Production Execute production as per plan To maintain the yield of products in specified limits at various stages of process activities. Manufacturing of products as per cGMP. On Line completion of batch process records. Quality Control On line verification of cleaning area / equipment and completion of Logs. On line monitoring of environment conditions and completion of Logs To maintain the process facility as per the regulatory norms. Production Planning To ensure appropriate validation activity of the production. On line completion of tooling and sieve records & documents. Maintenance To execute equipment qualification & ensure calibration compliance for equipment. Employee Training and Development Preparation of SOP’s. Job allocation to technician and monitoring the work done. Compliance To comply with cGMP standard during the entire process activity 5. KEY INTERFACES External Interfaces Internal Interfaces – Machineries Equipments RM/PM 6. EDUCATION & EXPERIENCE Education Qualification (Highest) with target Institution(s) : B.Pharm Desired Certifications : Experience Range : 7-8 years No. of years post Highest Qualification : 7-8 years Desirable Experience : 7-8 years of experience in Production Manufacturing area in approved pharma unit 7. SKILLS REQUIRED Skills Description Proficiency Level () Functional Skills : Basic knowledge of pharma process and handling production machinery of Dosage Forms manufacturing Knowledge about cGMP Exposure to Regulatory requirements like USFDA, MHRA etc . Behavioral Skills : Good Interpersonal Skills Team Building Skills Critical Thinking Ability to work in a diverse team Good Communication skills 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, 09 Jun 2022 22:43:19 GMT

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