4 Gamp5 Jobs

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114

Job Role: Mandatory area: Knowledge on 21 CFR Part 11 / EU Annexure 11, GMP, GAMP5 guidelines Adequate knowledge in CDS (preferably in Empower) and non-CDS applications. Knowledge in backup and restoration such as Veritas, Veeam, and Symantec. Knowledge of Computer System Validation Hands-on experience working in managing Active Directory, DNS, and DHCP Knowledge on Antivirus, Windows Patching activity including functionality & ease of using it. Daily Helpdesk troubleshooting and analytical approach while resolving various user calls. Adequate networking knowledge, including troubleshooting knowledge on LAN, WAN, and IP addressing. Hands-on experience in troubleshooting client end O365 Apps i.e., MS Outlook, Teams, One Drive, Excel, Word & PowerPoint Desirable Area Maintaining escalation matrix and understanding its requirement. Experience in documentation activities such as SOP preparation, change controls, and deviation handling. Knowledge of IP phone and EPABX management. Experience in CCTV camera systems and DVR/NVR management. Familiar with OS installation, configuration, and managing. Strong skills in laptop/desktop hardware troubleshooting.

Good understanding of the GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ICH Quality and other regulatory guidelines Review requirements, specifications, and technical design documents to provide timely and meaningful feedback. Experience in Validation life cycle of regulated projects GxP Awareness including Good Documentation. Practice Knowledge on Change control and Deviations, GAMP Categorization, Protocol Preparation, Vendor Evaluation. Good knowledge on pharma regulatory compliance processes and regulations Ensure all defined Process Engineering phases are reviewed, verified & defect removal is done. Take responsibility for creating the Project Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems. Performing Internal Audits as per annual inspection plan for GxP/GMP compliance and quality review. Capture the lessons and best practices in projects and suggest process improvements at the organization level. Conduct process related trainings and its tracking. Practice on Review for Requirement Specifications. (URS,FS and DS) Ensure that all sources are baseline and stored centrally in the central repository and local library of the project. Conduct baseline audits and reviews. Troubleshooting / investigating project defect database and bugs are classified. Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects. Experience in SDLC phases & Software Release strategy. Candidate should have work experience in software & Pharma industry.Role & responsibilities