142 Gamp Jobs - Page 4

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

Hi, We are having an opening for Manager IT - MES SME at our Halol or Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems. The Site SME MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution. The SME is also accountable for leading site-level validation activi...

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD,...

Role & responsibilities Strategic Responsibilities: Define and govern the corporate CSV strategy across all units/sites for GxP systems, including SAP HANA. Lead enterprise-wide validation projects ensuring alignment with GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and global data integrity expectations. Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation. SAP HANA Specific Responsibilities: Lead validation of SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process) across GxP operations. Prepare and maintain validation documentation including URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports for SAP HANA modules. ...

About AmpleLogic!! We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. Since 2010, AmpleLogic has been dedicated to developing industry-standard solutions that are effective, efficient, and competitive. With over 12 products deployed, including eQMS, LMS, DMS, and more, we have served 100+ life science companies worldwide. Our flagship product, eQMS, reflects our commitment to quality, compliance, and innovation. For more information, please visit: https://amplelogic.com/ About the role: Were seeking a detail-driven with .//. educational background having - - in (), , , . Wo...

Summary: Experienced Team member to handle Instrumentation & Automation (I&A) function in Drug Substance manufacturing plant. This role plays a critical part in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. To join a team of technicians responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems. Responsibilities: Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area. Perform qualification of I&A equipment according to cGMP and regulatory requirements. Troubleshoot and resolve I&A system malfunc...

About the Role: Grade Level (for internal use): 08 The Role Implementation Engineer The Team The Portfolio Analytics (PA) Application Support team is responsible for onboarding and supporting clients on the Capital IQ platform. Historically focused on manual ingestion workflows and reactive troubleshooting, the team is now evolving to take on a more technical, proactive, and scalable approach. This role will be key in driving that transformation building automation, scripting ingestion processes, and supporting API-based integrations. The Impact This is not just another support role. You will be part of the teams next chapter helping shift from manual operations to automated, scalable soluti...

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc. WFO, Mumbai - Immediate - 15 Days

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process...

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD,...

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones an...

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

SAP FI - Treasury Risk and Cash Liquidity Mgmt - Expert proficiency in SAP FI Treasury - Ability to read through the customer business processes and simultaneously formulating the adoption of the best business practices in meeting the foreseeable challenges Ability to review, validate the right set of questions Create solution workshops with senior business managers, review validate solutionproposals and estimates, rendering advice on best business practices and getting the buy in to adopt these practices Ability to create solution road maps integrating multiple disparate processes Ability to present and get the buy in forthe solution from senior managers Implement the solution by leading th...

SkillSAP FI-FSCD LocationPune and Bangalore Minimum of 4 years SAP experience Configure G/L, A/P, A/R, Asset Accounting, Interface Integrations, Experience on Collections and Disbursements (FS-CD) Experience providing application support Relevant SAP certifications are a plus Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of clients network/ server/ system/ storage/ platform/ infrastructure and other equipments to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the ...

Candidate must have hands on experience in Werum PAS-X/FTPS/Syncade/Opcenter development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES compon...

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR...

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least ...

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs l...

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams Take your career farther than you thought possible, Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms,/working-with-us , Position Summary Supports the execution of Computer Systems Validation (CSV) activities for systems and applications in Pharma GxP space under the guidance of Validation Lead/ Manager Collaborate with peer...

We are seeking a highly skilled and motivated Senior Analyst - Service Delivery Manager to oversee the services of our research applications and all associated service delivery activities in the Healthcare sector. In this role, you will foster a deep level of communication with the business teams to ensure effective solutions and high customer satisfaction. Have Outstanding verbal and written communication skills, along with the ability to understand service requests and incidents in healthcare, are key success factors. Manage end-to-end service delivery for resource applications, ensuring alignment with client expectations and business goals. Collaborate with cross-functional teams, includi...

Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations an...