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Jubilant Enpro
posted 14hr ago
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Job Description
Introduction:
Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America.
Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.
In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.
The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Find out more about us at www.jubilantpharmova.com .
The Position
Organization- Jubilant Pharmova Limited
Designation Executive-InformationTechnology
Location- Nanjangud, Mysore
Key Responsibilities.
- Must have Knowledge to perform the electronic data backup, restoration and verification as per the procedure for Manufacturing (FBD, DCS, TCU & etc) and Quality Control (Empower, Lab Solution, Tiamo, Newtronic, XRD, KF, FTIR, Malvern & etc) GxP systems.
- Responsible for perform the user management of all Quality Control & Manufacturing area computerised standalone and server & client based GxP systems.
- Responsible for administrative activity into the QC and Mfg computerised systems OS controls & hardening as per procedure.
- Responsible for all GxP computerised systems of Time synchronization & preventive maintenance and compliance, as per procedure.
- Responsible for all standalone instrument/ equipment systems security privileges, as per SOP and compliance. IT related SOP Preparation and implementation.
- Knowledge to prepare and execute the initial computer systems validation(CSV) of all GxP computerised instrument/ equipment systems, as per approved protocol.
- Responsible for troubleshooting of network issues in the instrument /equipment connected systems, related the communication, which is installed the respective GxP system applications.
- Responsible for root cause identifying with help of vendor or other CFT team members, to address the deviation or incident, related to IT systems failure.
- Responsible for initiate and action of the QMS element (CAPA, CC, Incident or deviation) related to IT activities, as per procedure.
- Knowledge for periodically security privileges verification from all quality Control and Manufacturing computerised GxP systems, as per procedure.
- Responsible for monthly project creation in Quality Control computerised instrument connected systems, as per procedure and monthly backed up data restoration.
- Knowledge and support to users SAP (PR, Service Entry, RGP NRGP), Track-Wise & EDMS application administrative related that enabled operations in the Nanjangud Business Unit.
- Knowledge for quality elements related to IT systems, as per GMP & 21 CFR Part11 guideline.
- Must have Knowledge for international regulatory audit ANVISA, USFDA & etc.
- Must have Knowledge for User management activity for enterprise applications connected instruments and equipment s GxP systems as per procedure.
Person Profile .
Qualification -Degree in Computers Science & Masters in Computer Science
Experience- 5-10 Years
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
No travel
Day Shift
Jubilant Enpro Benefits
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