Job title: Assistant Manager-Maintenance HVAC 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. JOB DESCRIPTION 1. DETAILS OF THE JOB Designation & Job : AM/DM – Utilities Level : 9A/10 Business Unit : Dosage forms & API Function : Engineering – Utilities Country : India Work Location : Roorkee Reporting Manager : Senior Manager – Engineering Manager’s Manager : DGM – Engineering Matrix Manager : – Team Size : 04-06 Direct Reportees : – 2. PURPOSE OF THE JOB Job Context: To ensure effective operation and upkeep of utilities as per the cGMP requirement Challenges: Keeping the utilities functional and maintained for facilitating uninterrupted supply of resources by assuring proper backup mechanism in case of breakdowns 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) Entire facility at Roorkee Plant 4. KEY ACCOUNTABILITIES Accountabilities Scope of work Control Validation and revalidation of Utilities and Facility. To ensure timely execution of preventive maintenance of Utilities, HVAC and water systems and their compliances records as per schedules. To ensure the timely calibration of measuring the instruments and control devices as per SOP’s. To ensure that complete utilities are operated at their maximum efficiency. To co-ordinate with various contractors, consultants to ensure smooth and fast working. Standardization Mapping & standardization of critical Instrumentation V/s Spares. Maintenance To maintain critical spares to handle preventive maintenance and B/D. To maintain the preventive maintenance and B/D maintenance records as per SOP’s. To maintain complete water system as per validated parameters, SOP’s user requirements. Employee Training and Development To Initiate SOP’s and compliance documents related with utility section of Engineering department. 5. KEY INTERFACES External Interfaces Internal Interfaces Vendors Auditors Equipments Instruments 6. EDUCATION & EXPERIENCE Education Qualification (Highest) with target Institution(s) : B.E (Mechanical or Electrical) Desired Certifications : – Experience Range : 9-13 years No. of years post Highest Qualification : 9-13 years Desirable Experience : 9-13 years of experience in Pharmaceutical Company 7. SKILLS REQUIRED Skills Description Proficiency Level () Functional Skills : Good knowledge of HVAC & Purified Water system, Good knowledge of Production machinery for Utility requirement Validation of HVAC, Water system & other Utilities Functional Knowledge Behavioral Skills : Multitasker who can work independently Ability to clearly explain technical subject matter to a wide range of audiences Good Interpersonal skills Desire and ability to learn new skills Knack for problem solving 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: Wed, 15 Jun 2022 22:41:17 GMT
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