InfoTech_ Manufacturing IT Team Lead

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

RESPONSIBILITIES:

Site OPS IT Lead to drive team of consultant engineers to provide support for manufacturing with respect to process systems Admin rights related activities in coordination with CFT.

1. Managing team of consultant engineers to ensure 24/7 support to Manufacturing

2. Maintain the systems always at compliant state

3. Protocols & SOPs preparation & review as applicable.

4. Handling SAP Plant maintenance module.

5. Having hands on with QMS modules such as Track wise, eVMLS, DMS, etc..

6. Maintain inventory list of Manufacturing/QC Automated System

7. Ensure the engineers performing / participating into qualification and validation of QC/Manufacturing Automated systems & firmware instruments from IT for various admin roles.

8. Review of qualification and validation documents of Manufacturing Automated systems including SCADA system from IT perspective covering 21 CFR Part-11 applicability, ER/ES, User & Role Management, Software Categorization, and Audit trail etc.

9. Ensure the engineers providing IT administrative support on Operating Systems (OS) & Application Software of Computer Servers, Desktops, Laptops, Industrial PCs, firmware instruments and Handheld devices etc., which are used in Manufacturing Automated Systems including SCADA systems at Site.

• User Management (Creation, Modification, Password reset etc.).
• User Access Rights Management on various drives, files and folders.
• Date and time Management.
• OS Policy Management.
• Backup & Restoration Management.
• Installation/ upgradation of Operating System, OS Service Pack/ Patch Management.
• Antivirus Management (if applicable).
• Periodic review of security audit trails & event logs (as where applicable).
• Provide support to vendor/OEM for fixing IT related issues during breakdowns.
• Upgradation of software, service packs, deployment of hot fixes, patches etc.
• Provide assisted admin access to QA/Regulatory authorities during audits (if applicable).

10. Initiation of QMS as per IT Operation requirements, investigation, CAPA implementation.

11. Participate in internal and external Audits to respond on IT related points for QC/manufacturing Automated Systems.

12. Ensures the electronic data security of the system administration.

13. Ensure the availability of procedures to maintain the system for Archival and Retrieval of data.

14. Responsible for supporting system specific risk mitigations.

Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.