95 Gxp Jobs - Page 4

Description Talent with Lifesciences domain experience with Manual testing and GxP testing skills Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade B Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family To be defined Local Role Name To be defined Local Skills Manual tester with GXP life science Languages RequiredENGLISH Role Rarity To Be Defined

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 7-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

QMS Consultant & Veeva Vault Project Support Analyst Role Overview We are seeking a professional with expertise in Quality Management Systems (QMS) and Veeva Vault to support the implementation, migration, and optimization of quality management processes. This role will focus on document and data migration, regulatory compliance, system integration, and ongoing support for Veeva Vault applications. The candidate will work from 5:30 PM IST 2:30 AM IST to align with the US time zone . Key Responsibilities Quality Management & Compliance Provide subject matter expertise on Vault R&D migration and quality management . Ensure quality standards, GxP compliance, and regulatory requirements (e.g., ISO 9001) are met. Conduct risk assessments to identify compliance gaps and inefficiencies. Define document classification and approval workflows aligned with industry best practices. Develop, implement, and maintain standard operating procedures (SOPs) and workflows for quality management. Manage change control processes , ensuring minimal disruption to quality standards. Implement post-migration quality checks to ensure document integrity. Provide ongoing monitoring and support for quality management tools and systems integrated with Veeva Vault. Track quality metrics, risks, and issues in compliance reports. Veeva Vault Implementation & Support Assist in migrating data and documents into Veeva Vault , ensuring accuracy and compliance. Collaborate with cross-functional teams to gather requirements and align migration activities with project goals. Provide technical expertise on Veeva Vault functionalities, workflows, integrations, and best practices . Conduct data quality checks post-migration to validate completeness and integrity. Troubleshoot technical issues and provide system support. Optimize automation, reporting, and regulatory compliance tracking within Veeva Vault. Communicate with both technical and non-technical teams to bridge business needs with system specifications. Identify, assess, and escalate potential risks related to migration and system integration. Training & Stakeholder Engagement Develop and update training documents and job aids for new Veeva Vault practices. Work alongside the Training & Procedures Team to provide comprehensive end-user training. Conduct product demonstrations and stakeholder engagement sessions to ensure seamless adoption. Gather and address stakeholder feedback to improve system functionalities and compliance adherence. Required Skills & Experience Technical & Functional Expertise 3+ years of experience in Veeva Suite, Veeva Vault, and Quality Management Systems (QMS) . Prior experience with Veeva migration support, data/document migration, and metadata mapping . Experience working with Veeva Vault Quality Suite , including workflows, document types, reports, dashboards, and notifications. Strong understanding of GxP, ISO 9001, and software validation regulations . Hands-on experience in testing, script execution, and system troubleshooting . Experience in configuring and resolving issues in multiple Veeva Vaults . Soft Skills & Qualifications Veeva Admin Certification is required . Bachelors degree in life sciences, computer science, or a related field . Strong analytical, problem-solving, and attention to detail skills. Excellent communication and interpersonal skills to work collaboratively across teams. Ability to influence stakeholders and manage change control processes effectively. Highly organized and detail-oriented with strong documentation skills. This role is ideal for candidates who can blend technical expertise with quality management practices while ensuring seamless regulatory compliance, data integrity, and system optimization within Veeva Vault.

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Job Job Title SAP FICO/R2R Solution Architect Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEs Technical and Professional Requirements: 15+ years of relevant SAP & domain experience Strong hands-on and in-depth knowledge of S/4 HANA FICO module Strong understanding of the Financial Accounting processes coupled with exposure to various P2P, O2C, M2D process scenarios, expertise in EBRR, Planning, FP&A & good understanding of taxation procedures, the relevant accounting treatment and the statutory compliance as per applicable Accounting Principles Thorough understanding of Agile and Activate methodologies Should have done at least two end to end implementation projects in S/4HANA as a Lead Functional Solution Architect Deep Knowledge and expertise in Finance BPML with an ability to guide clients to Industry Best practices Experience in leading and driving Business process workshops and Fit/GAP analysis Preferred Skills: Technology->SAP Functional->SAP Controlling Technology->SAP Functional->SAP Finance Technology->SAP Technical->SAP HANA Additional Responsibilities: SAP FICO / R2R with experience in any of the following industry (Pharma, Professional Services, Utility, Telecom, Oil and Gas/Public sector/Resources). The candidate is expected to play the role of an expert level Functional Solution Architect in large SAP transformation programs. The candidate should possess strong domain knowledge in Finance and should be experienced and adept at S/4 HANA SAP FICO module with hands-on expertise. S4 HANA Public Cloud module with hands-on expertise is an added advantage. Proactive approach to problem solving. Good understanding of GXP and SOX requirements Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services * Location of posting is subject to business requirements

Job Description : The candidate should possess following skillsets - > Experience working with LabVantage application > Sound knowledge in LabVantage configuration > Good understanding in Batch, Request, Sample, AQC, Instrument modules > Nice to have experience in Core JAVA and Webservice > Good to have prior work experience in GxP application.

Role & responsibilities 7-15 years experience IT CSV experience and not testers Validation of cloud systems Agile experience Vendor assessment experience Preferred candidate profile Perks and benefits

Greetings from Datakaar Private Limited. We are having opening with our client for Remote location for permanent Position you can work from pan India. We are looking for Immediate Position. Job Description: - Good knowledge of IT systems and different databases - Strong knowledge of IT systems and databases used in healthcare, including regulatory and pharmacovigilance databases - Experience in business requirements gathering, evaluation and preparation of URS/FRS documents - Excellent Business Process Analysis skills to evaluate the business processes, identify deficiencies and recommend improvements to optimize performance - Experience working in GxP environments and familiarity with computer system validation processes - Excellent communication and interpersonal skills. Tools: - MS Office 365 - Jira - Veeva Vault RIM and Veeva Vault QMS - ArisGlobal LSMV / LSRA - HPALM Only Interested candidate and Immediate Joiner share your resume @ amrita singh@datakaar.com and call on below number. Total Experience: 7 Years to 10 years Job Location: Remote Job Type: Permanent Notice period : Immediate Joiner. Thanks & regards, Amrita Singh 8210290845

Dear Candidate, We have an urgent openings for Tester role- PAN India Should have experience on GXP+ DeltaV+ OT Exp-8 to 14 yrs NP-90 days Location- Bangalore/ Pune/ Chennai/ Noida/hyderabad share your cv's on monal@thinkpeople.in

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

Job Description Overview: We are looking for a meticulous IT Manager to champion the integrity and efficiency of our IT infrastructure, ensuring alignment with stringent pharmaceutical regulations at Evertogen Life Sciences. As an IT Executive, you will maintain IT infrastructure, provide technical support, and ensure compliance with pharmaceutical industry regulations, including GxP and FDA 21 CFR Part 11. The ideal candidate will possess a blend of technical proficiency and regulatory understanding, capable of troubleshooting complex issues while upholding the highest standards of data integrity and cybersecurity. You will collaborate with cross-functional teams, manage vendor relationships, and develop comprehensive IT documentation and SOPs. With a focus on continuous improvement and adherence to best practices, you will play a pivotal role in optimizing our IT systems and ensuring the seamless operation of our pharmaceutical manufacturing processes. This role requires a proactive approach to problem-solving, a commitment to regulatory compliance, and a passion for leveraging technology to drive organizational success. Join us and be at the forefront of technological innovation in the pharmaceutical industry. Job Details: Industry: Pharmaceutical Department: Information Technology Role: IT Manager Location: Hyderabad Compensation: 15,00,000 per annum Experience: 10+ Years Employment Type: Full-time Qualification: Bachelor's degree in Computer Science or related field Responsibilities: IT Infrastructure Management Maintain and monitor IT infrastructure, including servers, networks, and hardware, to ensure seamless operations and minimize downtime. Install, configure, and upgrade computer hardware, software, and network systems used in the OSD pharmaceutical facility. Establish and maintain schedules for routine data backup and restoration processes to ensure data integrity and availability. Oversee network administration, including LAN, WAN, and VPN, to maintain a secure and efficient network environment. Manage server infrastructure, including Windows Server and Linux environments, ensuring optimal performance and security. Implement and manage virtualization technologies to enhance resource utilization and system scalability. Support and Troubleshooting Provide technical support to end-users for system-related issues, ensuring timely resolution and minimal disruption to operations. Troubleshoot IT issues related to hardware, software, and network systems, escalating complex problems as necessary. Perform preventive maintenance to minimize system downtimes and ensure the reliability of IT infrastructure. Manage incident response, including identifying, documenting, and resolving IT incidents in a timely and effective manner. Oversee software troubleshooting, diagnosing and resolving software-related issues to ensure smooth operation. Ensure Service Level Agreements (SLAs) are met for IT support services. Compliance and Security Ensure IT systems comply with pharmaceutical industry regulations, including GxP and FDA 21 CFR Part 11 requirements, and GAMP 5 guidelines. Implement and monitor data integrity measures across all systems to ensure the accuracy and reliability of data. Manage and maintain cybersecurity protocols to protect IT infrastructure from cyber threats and data breaches. Conduct regular security audits and risk assessments to identify vulnerabilities and implement appropriate security measures. Implement and enforce data access controls to protect sensitive information and ensure compliance with data privacy regulations. Ensure compliance with Good Laboratory Practice (GLP) guidelines in relevant IT systems. System Integration and Support Provide technical support for ERP systems (e.g., SAP) and LIMS used in OSD manufacturing and quality control. Support upgrades and migrations of critical systems, ensuring minimal disruption to operations and maintaining data integrity. Collaborate with validation teams to support computer system validation (CSV) activities and ensure compliance with regulatory requirements. Work with cross-functional teams to integrate IT systems with manufacturing and quality control processes. Manage vendor relationships for IT systems and services, ensuring timely and effective support. Provide support for cloud computing platforms used in the organization. Collaboration and Coordination Collaborate with QA, manufacturing, and other departments to align IT infrastructure with operational needs and ensure seamless integration. Work with external vendors for the procurement and maintenance of IT systems, ensuring cost-effectiveness and quality service. Train end-users on the effective use of IT systems and applications, promoting user adoption and efficiency. Participate in cross-functional meetings to provide IT input and support decision-making processes. Coordinate with IT teams to ensure consistent and reliable IT services across the organization. Act as a liaison between IT and other departments, facilitating communication and addressing IT-related concerns. Documentation and Reporting Maintain accurate records of IT assets, incidents, and system configurations, ensuring comprehensive documentation for auditing and troubleshooting purposes. Generate reports on system performance, security incidents, and IT compliance, providing insights for continuous improvement. Develop and update standard operating procedures (SOPs) for IT processes, ensuring consistent and compliant operations. Maintain IT documentation, including system diagrams, network configurations, and user manuals. Create and maintain a knowledge base of common IT issues and solutions for end-users. Ensure that all IT documentation is up-to-date and readily accessible to authorized personnel. General Expectations and Past Experiences: Possess a Bachelor's degree in Computer Science or a related field with at least 10 years of experience in IT infrastructure management within a regulated environment. Demonstrate a strong understanding of pharmaceutical industry regulations, including FDA 21 CFR Part 11, GxP, and GAMP 5 guidelines. Exhibit proficiency in troubleshooting IT issues related to hardware, software, and network systems, with a focus on minimizing downtime. Experience with ERP Systems (e.g., SAP) and LIMS Systems, including implementation, maintenance, and support. Proven ability to develop and maintain IT Documentation and Standard Operating Procedures (SOPs) to ensure compliance and consistency. Hands-on experience with Network Administration (LAN, WAN, VPN) and Server Management (Windows Server, Linux). Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams and external vendors.

About The Role : Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Individual contributor for Quality, Compliance, and Good Documentation Practices Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Primary Skills Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Secondary Skills Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Individual contributor for Quality, Compliance, and Good Documentation Practices

Product Validation ~Documentation Control ~Equipment Validation & Qualification ~Product Lifecycle Management ~Defect Management ~Project Handling Expertise Knowledge of FDA regulations, EU guidelines, CSV, GAMP guidelines and product development process. Ensuring the quality compliance with respective areas and GxP guidelines. Significant exposure in maintaining & ensuring stringent adherence to quality, identifying gaps, norms & practices. Abilities to understand their requirement related to product they need and deliverables. Abilities in implementing quality plans with focus on identifying gaps. Key result Areas: Execution and compliation of CSV Qualifications for all the GxP applications in Manufacturing area. Execution of Qualification activities IQ, OQ, PQ for all GxP systems in the manufacturing process equipments. Administration and User Management of all the laboratory applications, Instruments, Manufacturing process Equipments as per SOP. Vendor co-ordination for all the IT related news projects and requirements. Co-ordination with CFT's for qualification document approvals. Performing the User ID Role Matrix, Manual Backup periodic activity as per SOP. Ensuring that validation activities align with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and other applicable guidelines. Ensuring all documentation aligns with regulatory expectations and internal quality standards. Responsible for curation and review of quality and validation documents with assurance of GxP compliance, adherence to safety polices. Responsible for knowledge sharing to new joiners on projects and standard operating procedure. Responsible for putting ideas and suggestions to teams with respect to process & projects.

Position - Quality Operations Analyst Ideal Background / Requirements for the role: • M. Pharm/ MBA / Engineering/equivalent from a reputed institute. Skills- QMS elements from Pharmaceutical Quality Assurance Change Control is primary preferable however others can also be taken into consideration hands on exp on QMS tools AQWA, Trackwise, SAP Location- Hyderabad Duration- 1year Preferably local/ Hyderabad work mode- Hybrid 3 days in office , general shift Budget- up to 8.5 LPA Min 2-6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. • GMP -knowledge, Broad IT-knowledge • Fluent in English (written and spoken) • Good communication, presentation and interpersonal skills • Experience of working closely with the global stakeholders Roles & Responsibilities: Common Accountabilities: (Applicable to all services in QOP) • Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes • Assist the department on any other ad hoc activities/ requests to meet the business requirements • Regularly communicate with partners and obtain feedback on services delivered • Focus on timely completion of all relevant and assigned trainings • Learn & develop understanding to generate insights through data and digital Ensure responsibility and ownership of the assigned tasks • Comply with accuracy and timeliness of deliverables Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements • Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed • Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports • Adherence to the current GxP and compliance policies of organization Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows • Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables • Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required • Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures • Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers • Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes • Assist the department on any other ad hoc administrative activities as per business requirements Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable • Oversight on BOT regular performance and support the BOT validation activities as per business need • Support the Master Data Management to the required sites as required Change Control Management: • Manage different types of change control like product stewardship/Administration Stewardship/Asset Stewardship in electronic systems like TrackWise and/or Agile from Change Initiation to closure as needed • Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions as required. Perform Regulatory assessment on Change Controls as needed. Perform deviation investigations and CAPAs as part of change management. • Artwork Second Independent Check/M05 or Artwork Second Independent Text Reviewer or Approver Interested candidates share cv : busiraju.sindhu@manpower.co.in Whats App : 7013970562

Dear Aspirants, WE ARE HIRING TULIP DEVELOPER LOCATION : PAN INDIA NOTICE PERIOD: IMMEDIATE TO 30 DAYS Job Description: Responsibilities: Develop and maintain applications using Tulip in a GXP-compliant environment. Collaborate with cross-functional teams to design, develop, and implement solutions that meet business requirements. Ensure compliance with regulatory standards and guidelines in the Life Sciences and pharmaceutical domain. Utilize data modelling and Unified Namespace technologies like HighByte, HiveMQ, EMQX, and Litmus to enhance data integration and communication. Implement and manage IIOT or Lite MES platforms to support various business operations. Work in an Agile methodology to deliver high-quality solutions on time. Troubleshoot and resolve technical issues related to Tulip and other integrated systems. Provide technical guidance and mentorship to junior developers. Requirements: Bachelor's degree in Computer Science, Engineering, or a related field. Proven experience as a Senior Developer with expertise in Tulip. Strong understanding of the Life Sciences and pharmaceutical domain and experience working in a GXP-compliant environment. Proficiency in data modelling and Unified Namespace technologies like HighByte, HiveMQ, EMQX, and Litmus. Experience with IIOT or Lite MES platform development. Excellent problem-solving skills and attention to detail. Strong communication and collaboration skills. Excellent team player with experience working in an Agile methodology. Nice to Have: Experience with other IoT platforms and technologies. Knowledge of industry best practices and emerging trends in the Life Sciences and pharmaceutical domain. If your interested please reach out to ponnala.kumari@orcapod.work Thanks Kumari

Joining timelines: immediate to 1 month Candidate should have a minimum of 8+ years overall Experience Relevant should be at least 2-3 years with lead exp Should have extensive experience in Test documenation like Test Plan, RTM, Test Strategy, Test Data, Bug Report, Test execution report including Test Case creation, and Defect Handling (severity Vs priority) Hands-on experience in Validation test plan, Validation test strategy Validation test documentation, and guiding Should have strong experience in Manual Testing Experience in Test case execution and Bug fixes. should be ready to work as individual contributor too along with Lead role. Experience in Test management tools (Jira and ALM),Knowledge of DB testing Expertise in performing different types of testing like Functional Testing, System Testing, Regression Testing. good to have :Life science or Clinical Trail Domain Experience Working in an Agile environment. We also offer: o Group Health Insurance covering family of 4 o Term Insurance and Accident Insurance o Paid Holidays & Earned Leaves o Paid Parental LeaveoLearning & Career Development o Employee Wellness

Role:LIMS Consultant Year of exp:8to15yrs About The Role :: LIMS / ELN professionals with an exceptional track record of at least 10 years in a significant leadership role involving LabWare LIMS / ELN Professional development: Strong desire to build a long-term career in LabWare LIMS. Configuration of LabWare LIMS and ELN products Other LIMS / ELN products will be added advantage. Databases (Oracle, SQLServer), SQL, LIMS Basic programming, XML, HTML, Crystal Reports. Server-based architecture Web deployments Citrix deployments, web services. Laboratory instrument interfacing, ERP systems interfacing. Project Management Business Analysis Validation

Work profile: Plant IT Operations (Pharma and Biotech) Job Location: Bangalore / Pondicherry / Chennai Qualification: Diploma or Degree in Engineering Experience: 7-9 years (L2) Duration : 1 year contract Role & responsibilities: Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for enterprise-level applications, addressing technical issues and maintaining operational continuity. Configuration of software, peripheral devices, and upgradation and troubleshooting for enterprise applications hosted on Windows servers. Capable to handle GxP and non-GxP incidents and tickets related to backups, file management, user management, and security within SLA, and hardware and software maintenance to improve network performance and reduced downtime. Coordination with cross functional team for requirement gathering, review and finalizing technical specifications for IT infrastructure systems. Basic understanding business requirements from users. System administration for GxP application users and project Creation/Disable/modification records. Maintain the disaster recovery plan and backup. Should have good knowledge of QMS process include handling investigations, Change controls and deviations. Backup and Restoration for GxP Systems for Laboratory and Mfg. systems. Should be capable to Coordinate with external engineers/vendors of QC and ensure the services of equipment and applications. Provide technical and functional support to the teams, maintaining the team and giving support to end users for day-to-day activities along with reviewing team Daily reports weekly reports, and Monthly reports and preparing necessary documents. Configuring and troubleshooting of the Network and printers, Configuring and troubleshooting of LAN on Windows platforms. Installation and troubleshooting of Desktops and Workstations.

Job Title: Executive IT/ System Admin Duration: 1 Year Contract Start Date: ASAP No of Positions: 10 Work Locations: Bangalore, Pondicherry Experience: 2 to 3 years of experience in Pharmaceutical/ Manufacturing Plant IT Roles & Responsibilities: Software installation/uninstallation and application troubleshooting. Installation of application for the end user. Administration management for GxP applications. Data backup and administration as well as infrastructure management. Network connectivity troubleshooting to resolve user connectivity issues. Maintain essential IT operations, including operating systems, security tools, applications, servers, email systems, laptops, desktops, software, and hardware. Strong communication skills.

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Computer System Validation (CSV) Good to have skills : Life Sciences Minimum 2 year(s) of experience is required Educational Qualification : BE Summary :As a Tech Delivery Subject Matter Expert in Business Process Architecture, you will be responsible for driving innovative practices into delivery, bringing depth of expertise to a delivery engagement. Your typical day will involve using your expertise in Computer System Validation (CSV) to analyze, design and/or implement technology best practice business changes, while working directly with clients in a trusted advisor relationship to gather requirements. Roles & Responsibilities: Lead the analysis, design and/or implementation of technology best practice business changes using your expertise in Computer System Validation (CSV). Collaborate with cross-functional teams to ensure successful delivery of projects. Provide subject matter expertise to clients and internal teams on Computer System Validation (CSV) and related topics. Stay updated with the latest advancements in Life Sciences and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Life Sciences. Strong understanding of business process architecture and related technologies. Experience in collaborating with cross-functional teams. Excellent communication and interpersonal skills. Additional Information: The candidate should have a minimum of 2 years of experience in Computer System Validation (CSV). Qualification BE