Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs”). Our focus is primarily on niche therapeutic areas and complex products. We market and distribute our products in over 40 countries.
Natco Pharma Job vacancy For Following:
- Department :Information Technology
- Experience : 02 to 06+years
- Qualification : B. Tech (CSE ) / B.Sc. Computers
- Location: Hyderabad/ Secunderabad,Telangana
- Designation: Officer / Executive
- No.of Openings: 02
Interested candidates with relevant experience can share their resumes to Mail: [email protected]
Job description:
Greetings from Natco Pharma Limited..!!
We are looking for the following requirement for our API Manufacturing facility at Mekaguda (Near to Shadnagar)
Only API manufacturing experience can be considered.
Department: Information Technology
Designation: Officer / Executive
Experience: 4 to 5 years in System Administration
Qualification: B. Tech (CSE ) / B.Sc. Computers
Work experience: QC GXP information systems and applications
- To prepare and support the Operational and administration of software-related instrument SOPS.
- Managing users in an Active Directory environment and applying Group Policies for users.
- User & Group Management in Windows Servers.
- Ensure IT Compliance as per standards to comply with FDA regulations.
- Project & Folder Creation of QC Lab Instruments like Empower, IR, FTIR, UV Probe, TOC-L, Tiamo, XRD, GC, LC-MS, ECM,etc
- Responsible for administrative activities of all the Laboratory equipments application software.
- Managing QC LAB instrument Computers & Production Computers as per the Audit Compliance by applying data restrictions.
- Ensure Data integrity and security of all instruments connected to lab PCs.
- User ID Creation for all Production Equipments.
- Installing and configuration of all Production System OS like Granulation (HMI, MMI & IPC), Compression IPC Systems.
- Good knowledge of Maintaining the Antivirus McAfee server (Web Controller, Thread prevents, DLP,).
- Configuring & Troubleshooting Outlook Issues.
- Good knowledge of Maintaining hardware and software installation and troubleshooting.
- Good knowledge of Maintaining Backup applications Veeam/Veritas and troubleshooting.
- Investigation and root cause analysis for IT system failures.
Department: Information Technology
Designation: Asst Officer / Officer
Experience : 3 to 4 years in Computer System Validations
Qualification: B. Tech (CSE ) / B.Sc. Computers
Work experience: Computer System Validations
- Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control Management testing and implementation of business applications.
- Should have experience in the Implementation of Lab & QMS Applications like LIMS, Empower, DMS, eLogbook, DMS, TrackWise, SAP ,etc.
- Good knowledge of Computer system validations like GAMP 5 Categorizations of all the QC and Production workstations, servers, IPC Systems, HMI, and MMI.
- Experience in GAP Analysis and documenting Remediation Plan.
- Experience in Preparation of Risk Assessments.
- Experience in Creating Test Scripts e.g. UAT, IQ,OQ,PQ etc.
- Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21CFR Part 11 and FDA regulations for the pharmaceutical industries.
- Capability to quickly gain a detailed understanding of a process to optimize efficiencies and improve quality.
- Experience in applying FDA regulations to the aspects of Computer and Lab Systems.
- Experience in Conducting Training to the CFT(s) on 21 CFR Part-11 Validation, EU GMP Annex11 Assessments, SOPs etc.
- Aware of Good Documentation Practices.
Relevant experienced and Interested candidates can drop CV’s to [email protected]