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Mgr.-Serialization Specialist

Location Greater Noida, India
Posted 09-September-2021
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 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 its 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. RD 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.

JGLs 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.

Job Context:
The Technical Serialization Specialist of Jubilant Pharma will be responsible for day-to-day management of the RfXcel Serialization aspects of operations. The Technical Serialization Sr. Specialist is responsible for ensuring maintenance for existing and execution for new product introductions, and all aspects of serialization are established and maintained in accordance with GS1 regulatory standards.

Should be comfortable to work in EST time Zone (Shift 3 PM12 AM)

Key Responsibilities:
Serialization Support Activities including Upgrades Change Requests:

Support Sr. Serialization Manager in Managing maintaining Rfxcel software to ensure smooth operations
Management of 3rd party vendors and ensuring interfaces between systems are maintained and validated according to Jubilant Pharmas policies and procedures
Supporting interfacing internally between Optel / Xytech/ Jekson /SAP with rfXcel
Manage Serialization Issue Log and be able to interpret EPCIS events according to the GS1 standards
Lead resolution of all issues associated with serialization, under guidance of Sr. Manager Serialization Jubilant Pharma
Audit trail and data review with the understanding of 21 CFR PART 11.
Assist in the support for the development of specifications for Labeling and Packaging
Manage Verification Router Service (VRS) and interface with customers to establish required connections
Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, Unit test scripts, UAT scripts, Risk assessment.
Execute scripts to validate new functionality / upgrades / to rfXcel to keep current on new releases, including VRS, iVeda, unit level serialization, EPCIS 1.2, and any other Government regulations worldwide.
Support Sr. Serialization Manager in the development of department SOPs and help provide SOP review for new systems.
Collaborate with SAP Support team with close integration for serialization.

Collaboration with Quality and other functions

Collaborate to ensure serialization standards are met
Coordinate all serialization activity and system interfaces with the appropriate team such as: GXP, IT, Production, Quality and Regulatory
Manage change controls and deviations associated with Serialization as well as issuing CAPAs as required

CMO Onboarding

Championing CMO onboarding activities as it relates to serializationInterfacing with labeling team to confirm new products/standards are ready for operation in serialization systemsEducation Qualification(Highest ): Bachelor or Masters in Computer Science or related field

Experience Range : 7-10 Years

No. of years post Highest Qualification : 7-10 Years

Desirable experience : Minimum 5 years of Pharmaceutical Experience, Experience of managing Serialization essential. RFXcel preferable., Supervisory Experience, FDA Regulated Industry Experience

Functional Skills (Functional Expert)-

MS Excel, Powerpoint, WordStrong knowledge of Global Serialization Standards (GS1), regulatory requirements and guidance, with solid understanding of cGMP complianceFunctional Skills (Working knowledge)

EPCIS Systems, Trace Link, Lspedia, MediledgerExperience interfacing with Optel, Xyntech, Jekson is a plusBehavioral Skills -

Good verbal and written communication skills, self-driven and willingness to work individually and adapt new technologiesManaging conflicts and influencing outcomesMust possess excellent communication skills and have the ability to effectively interpret needs and requirements at the business process level as well as at the technical levelAbility to work independently and in a team environment.Creativity as a problem solver.Creative thinking skills.Detail-oriented personality.Tolerance for ambiguity.Ability to manage multiple projects effectively

 
Awards & Accolades for MyTechLogy
Winner of
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Finalist at SiTF Awards 2014 under the category Best Social & Community Product
Finalist at HR Vendor of the Year 2015 Awards under the category Best Learning Management System
Finalist at HR Vendor of the Year 2015 Awards under the category Best Talent Management Software
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