AM | Quality Control Jubilant Ingrevia Limited

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 6+ 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 -1+ it was INR 53,240 Million as compared to INR 3+,+50 Million during the Financial Year 2017-18.

Kindly refer www.jubilantpharma.com for more information about organization.

Position

Assistant Manager - QC

Grade : L1

Business Unit / Function

Department – Quality Control

Location

Bharuch SEZ

Reports to

QC Head

Summary

Summary of Job

(Purpose/ objective of the job Department Organogram to be enclosed)
• candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO+001, FSSC, HACCP / global QMS requirements at SEZ site.

Key Responsibilities

(Performance Indicators)
• Regularize the QC activities as per cGMP requirements.
• Regulatory & Pharmacopeia requirement for lab compliance.
• Review of hybrid & electronic data for IPQC & FG analysis.
• Analytical method validation, OOS & OOT.
• Knowledge about IMS system (ISO +001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP.
• Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc.
• Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches.
• Resolve the trouble shooting related to QC activities.
• Training to subordinate & employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab.
• Awareness about responsible care (Environment, Health, Safety and Security)

No. of Reportees

2-3 numbers

Qualification & Experience
• M.Sc. (Chemistry) with 8-12 yrs.

y Competencies (Technical, Functional & Behavioral)
• Responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP.
• Hand-on experience as Reviewer of electronic data & hybrid system in regulatory environment (US-FDA, WHO etc.)
• Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

Site Quality Head

CQA & RA Head