142 Gamp Jobs - Page 3

Provide expert consulting on designing, optimizing, and implementing quality management systems, ensuring alignment with industry best practices and regulations. Required Candidate profile 3+ years eClinical software exp; 8+ years in quality assurance/compliance/management within U.S. pharma; Deep knowledge of regulatory frameworks: FDA regulations, ICH GCP, 21 CFRPart 11.

As a dedicated Qualification Professional, you will be responsible for overseeing the execution of Pre-Factory Acceptance Tests (Pre-FAT), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) in accordance with established test protocols. Your primary role will involve engaging directly with customers to ensure adherence to test specifications and securing necessary documentation and approvals during FAT at our facilities and SAT at customer locations. You will be expected to conduct thorough testing and troubleshooting of systems, including SCADA, to ensure optimal performance. Additionally, you will monitor and address Non-Conformance Reports (NCRs) arising during Pre-FAT, FAT, ...

Job Title: Machine Learning Engineer Job Type: Full-time About Us: Our mission at micro1 is to match the most talented people in the world with their dream jobs If you are looking to be at the forefront of AI innovation and work with some of the fastest-growing companies in Silicon Valley, we invite you to apply for a role By joining the micro1 community, your resume will become visible to top industry leaders, unlocking access to the best career opportunities on the market, Job Summary Join our customer's team as a hands-on Machine Learning Engineer, where you'll play a pivotal role in shaping, deploying, and automating end-to-end machine learning pipelines Leveraging your expertise in AWS ...

As a qualified candidate passionate about delivering computer system validation and risk management approaches to support tremendous IT and business growth, you will join the IT team as part of the ITRMC (IT Risk Management & Compliance). In this role, you will interface between the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, the business plans to deploy major operational systems like LIMS, ERP, MES, VLMS, EBR to enhance capabilities and improve customer service, and you will play a crucial role in achieving these objectives. Your responsibilities will include providing technical ...

Role & responsibilities Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc.. Must know about GAP assessment Must have exp in handling CSV of L1 , L2 system like DAS, DCS, Empower ,OSD /injectable Mfg equipment Must have knowledge for performing category 4 and 5 system Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR Execution of qualification document without DI

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP FI CO Finance Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with various teams to understand their needs, developing solutions, and ensuring that applications function effectively to support business operations. You will engage in problem-solving and decisi...

Computer System Validation (CSV) Exp. :- 3-9 yrs Location :- Pune Work youll do As a part of our Technology & Transformation team, Youll: Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively...

This Position reports to: Senior Engineering Manager In this role, you will have the opportunity to act as a design authority for an engineering discipline with low to medium complexity. Each day, you will complete assignments on small projects or portions of larger projects in a cost-effective manner. You will also showcase your expertise by applying basic design thinking/design for excellence concepts in projects. This role is contributing to the Process Automation business for Energy Industries division based in Bangalore, India. You will be mainly accountable for: Engineering and Project Deliverables to Commissioning Involves: A person with good automation and Pharma, Biotech/API, Food &...

This Position reports to: Senior Engineering Manager In this role, you will have the opportunity to act as a design authority for an engineering discipline with low to medium complexity. Each day, you will complete assignments on small projects or portions of larger projects in a cost-effective manner. You will also showcase your expertise by applying basic design thinking/design for excellence concepts in projects. This role is contributing to the Process Automation business for Energy Industries division based in Bangalore, India. You will be mainly accountable for: Strong expertise in automation within Pharma, Biotech/API, and Food & Beverage industries. In-depth knowledge of Batch standa...

Educational Requirements Master of Pharmacy,Master Of Technology,Bachelor of Pharmacy (Honors),Bachelor Of Science,Bachelor of Engineering,Bachelor Of Technology 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...

Looking for a qualified candidate with a passion for delivering computer system validation and risk management approaches to support significant IT and business growth. As a part of the ITRMC (IT Risk Management & Compliance) team, you will work closely with the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, our organization plans to deploy major operational systems like LIMS, ERP, MES, VLMS, and EBR to enhance capabilities and improve customer and patient service. Your role will be crucial in achieving these objectives. Your responsibilities will include providing technical and comp...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, repo...

Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit tra...

Major Purpose of the Job: (Exactly spell out key deliveries/results expected from this job) Person should have minimum 12+ years of experience in SAP-PP, SAP-QM, SAP-PM modules Should have implementation experience of S4HANA (Minimum one project) Ensuring Smooth Functioning of SAP-PP/QM/PM modules. To Provide Support in SAP-PP/QM/PM modules for all companies of Cadila. This will include SAP-PP/QM/PM module configuration also. Principal Accountability: (Please write all the major jobs that the employee is required to carry out ) Supporting users in Day to day issues in SAP-PP/QM/PM modules for all companies of Cadila. Knowledge on Product costing (Production order/Process order), MRP, Order e...

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts

Job Title: CSV Engineer Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences About the Role: We are looking for a CSV (Computer System Validation) Engineer with hands-on experience in the pharmaceutical, biotechnology, or life sciences sectors. You will be responsible for ensuring that systems are validated in compliance with regulatory requirements and internal quality standards. Key Responsibilities: Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines Conduct im...

Hi, We are having an opening for Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 7-9 years of experience in the pharmaceutical industry, including hands-on expertise in Manufacturing Execution Systems (MES) and L2 integration. The Site Project coordinator for MES Implementation will be the primary coordinator for all MES-related activities at the Halol / Baska sites. This role demands dedicated full-time support to the project to ensures smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation. T...

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessmen...

About the Opportunity Job TypeApplication 31 July 2025 Title Supplier Relationship Manager Department Procurement Location Gurgaon, India Reports To Head of Supplier Relationship Manager Level Grade 5 We are proud to have been helping our clients build better financial futures for over 50 years. How have we achieved thisBy working together - and supporting each other - all over the world. So, join our team and feel like youre part of something bigger. About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe,...

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Require...

CSV L1/L2 Support Validating, Reviewing and updating validation documentation Hands on exp in CSV principles and GxP compliance. Experience in validation practices with hands on exp in 21 CFR Part 11/ EU Annex 11 /GAMP 5 Guidelines /GxP Standards

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders an...

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the o...