24 Gamp5 Jobs

As an Engineer A&C Master Software, your main role is to design Control Architecture and program PLC/HMI/SCADA software based on project requirements. Your responsibilities include: - Developing Master Application Program in PLC following IEC61131 compliant programming language - Ensuring thorough testing and a first-time-right approach before releasing software program to operation and manufacturing teams - Designing, creating, and testing PLC Level 1 module software code for product release - Developing Servo drive software code for product release and PLC level 1 modules - Creating VFD code and settings via PLC level 1 modules for product release - Designing PLC Level 2 & 3 product code, ...

About the Role We are seeking a LabWare LIMS Developer to design, configure, and maintain LabWare Laboratory Information Management Systems (LIMS) across R&D and Quality Control environments. The role involves hands-on configuration, workflow automation, and system integration to support laboratory operations efficiently and compliantly. The ideal candidate will bring both technical proficiency and business understanding to ensure reliable, compliant, and high-performing LIMS solutions. Key Responsibilities LIMS Configuration & Development: Customize and configure LabWare LIMS to meet laboratory requirements. Develop and maintain workflows, templates, and reports. System Integration: Integra...

Job Description: You will be required to visit the client place to perform CSV activities. Your responsibilities will include: - Having knowledge of GAMP5 and 21CFR Part11 - Experience in preparation of validation deliverables - Performing validation activities Kindly note that additional details of the company are not provided in the job description.,

Job summary As a Pharma IT - CSV, you will be responsible for the validation of all GxP-relevant computerized systems used across manufacturing, quality control, and R&D. Your role is critical in ensuring all IT systems meet regulatory requirements from agencies like the US FDA, MHRA, and others. You will manage the entire system validation life cycle, from planning to retirement, within a highly regulated pharmaceutical environment. Responsibilities Validation life cycle: Plan, execute, and document computer system validation activities in accordance with GAMP5 guidelines and internal Standard Operating Procedures (SOPs). Regulatory compliance: Ensure all computerized systems and processes ...

As a Delivery Executive for Smart Factory programs in Life Sciences and Medical device sectors, your role will involve leading and overseeing MES/MOM implementations, Industry 4.0/Pharma 4.0 initiatives, and IT/OT integration across global manufacturing sites. Your deep domain expertise in life sciences, strong program & Delivery governance, and ability to drive value realization through digital innovation will be crucial for success. **Key Responsibilities:** - Lead large-scale MES/MOM, Industry 4.0/Pharma 4.0, and IIOT/Manufacturing Data Platform initiatives across multiple sites, ensuring compliance with GxP and regulatory standards. - Act as the delivery interface for geography and clien...

Job Description As a Senior Lab Informatics Specialist, you will lead the deployment, customization, and optimization of Agilent's informatics solutions (OpenLab CDS server, etc.) across complex laboratory environments. You will act as a strategic advisor to clients, ensuring seamless integration of lab systems, regulatory compliance, and digital transformation. Key Responsibilities: Lead end-to-end implementation of Server client networks and OpenLab platforms in regulated labs. Architect integration solutions between lab instruments with Servers and enterprise systems (ERP, MES). Drive customer workshops to gather requirements and design tailored informatics workflows. Ensure compliance wi...

Skills: IT Deskop, Desktop Support, 21 CFR, Pharma IT, Manufacturing IT, Backup & Recovery Systems, INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) is on the lookout for passionate and experienced professionals to join our team as IT Desktop Support for Bangalore locations in India! Locations: Bangalore Experience: 28 Years in Manufacturing IT / Plant IT / QC-IT (Preferably in the Pharma Sector) What Were Looking For Hands-on experience in MFG-IT, Plant-IT, QC-IT Knowledge of Pharma Guidelines, IT SOPs, and Pharma Compliance Familiarity with 21 CFR Part 11, GAMP5, CSV, Empower Software Skills in User Management, Backup Management, and System Inventory If you're ready to bring your expertise into...

Skills: IT Deskop, Desktop Support, 21 CFR, Pharma IT, Manufacturing IT, Backup & Recovery Systems, INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) is on the lookout for passionate and experienced professionals to join our team as IT Desktop Support for Bangalore locations in India! Locations: Bangalore Experience: 28 Years in Manufacturing IT / Plant IT / QC-IT (Preferably in the Pharma Sector) What Were Looking For Hands-on experience in MFG-IT, Plant-IT, QC-IT Knowledge of Pharma Guidelines, IT SOPs, and Pharma Compliance Familiarity with 21 CFR Part 11, GAMP5, CSV, Empower Software Skills in User Management, Backup Management, and System Inventory If you're ready to bring your expertise into...

Job Type : Long-Term Contract About The Role We are looking for an experienced CSV Lead with deep expertise in Computer System Validation, SAP S/4HANA upgrades, and strong Japanese language proficiency (JLTP N1). This is a remote, long-term contractual role ideal for a proactive professional who can manage validation activities and compliance processes independently while collaborating in a global, cross-functional environment. Key Responsibilities Lead and manage CSV (Computer System Validation) activities across the project lifecycle, including concept, implementation, operations, and retirement phases. Work closely with teams involved in SAP S/4HANA upgrade initiatives. Review and approve...

Job Title: Automation + Pharma Validation Trainer Location: Remote Job type: Part-time Job Summary: We are seeking an experienced trainer to deliver hands-on training in Automation systems and Pharma Validation . The role involves designing training modules , mentoring candidates , and preparing them for industry certifications , regulatory audits , and interviews . This position is ideal for professionals with a strong background in pharma automation , CSV , and regulatory compliance who are passionate about teaching and career development . Key Responsibilities: Conduct training on Automation systems ( SCADA, PLC, DCS ) and Pharma Validation ( CSV, IQ/OQ/PQ, 21 CFR Part 11, GAMP5 ) Build m...

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...

As a Techno-Functional Consultant at Strateena, you will be responsible for providing production support, performing enhancements, and upgrades for the Oracle EPM Platform. Your role will involve interacting with business stakeholders, gathering requirements, documenting business processes, and providing business insights. Strong communication skills are essential for effectively addressing client's business requirements and solving business problems using Oracle EPM applications. Your finance business process knowledge and hands-on experience with Oracle EPM Cloud will be crucial in providing business solutions and reducing the use of PaaS solutions. Your main responsibilities will include:...

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

Skills: IT Desktop Support, IT Support, 21 CFR, Pharma IT, QC-IT, MFG-IT, Back up, Data Restoration, INSTRUMENTATION AND CONTROL SOLUTIONS (ICS) is on the lookout for passionate and experienced professionals to join our team as IT Desktop Support for Bangalore locations in India! Locations: Bangalore Experience: 28 Years in Manufacturing IT / Plant IT/QC-IT ( Preferably in the Pharma Sector) Role - IT Desktop Support Role What Were Looking For Hands-on experience in MFG-IT, Plant-IT, QC-IT Knowledge of Pharma Guidelines, IT SOPs, and Pharma Compliance Familiarity with 21 CFR Part 11, GAMP5, CSV, Empower Software Skills in User Management, Backup Management, and System Inventory If you're rea...

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of e...

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 an Engineer A&C Master Software at our company serving pharmaceutical and nutraceutical companies worldwide, you will be responsible for the control architecture design and PLC/HMI/SCADA software programming as per requirements. Your main duty will be developing the Master Application Program in PLC for products utilizing IEC61131 compliant programming language. It is essential to ensure thorough testing and a first-time-right approach before releasing the software program to the operation and manufacturing teams. You will be accountable for the design, creation, and testing of PLC Level 1 module software code to release Product code PLC Level 1 modules. Additionally, your role will invol...

Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Job Description Designation: Deputy Manager Level: 7 - II Job Location: Bangalore The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combina...

Strateena is currently seeking a Techno-Functional Consultant at Grade Level 4 with expertise in Oracle EPM to provide support, enhancements, and upgrades for their Oracle EPM Platform. The ideal candidate should possess strong communication skills to effectively engage with business stakeholders, gather requirements, document processes, and offer valuable business insights. In this role, you will be responsible for delivering end-to-end solutions that meet client's business requirements and address business challenges through the utilization of Oracle EPM applications. A robust background in finance business processes and hands-on experience with Oracle EPM Cloud is essential for providing ...

JOB OVERVIEW: To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business Site / Corporate functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to Chief Manager- IT CSV EXPERIENCE: Candidate with 3-6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable SKILLS AND COMPETENCIES Experience in ...

Position Summary This role offers a compelling opportunity to work with leading clients in the life sciences and healthcare space, supporting regulatory compliance, governance, and quality system validation initiatives. Youll be part of a dynamic team, driving innovation and ensuring adherence to global standards in regulated environments. Key Responsibilities Regulatory Compliance: Identify and manage regulatory risks to support clients in compliance, governance, and control frameworks. Project Leadership: Lead and coordinate cross-functional teams for new product development, system validations, and quality assurance activities. Process Improvement: Assist clients in developing strategies ...

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 (I...

Role & responsibilities Position Summary: We are seeking an experienced Quality Engineer (QE) with a strong understanding of Good Manufacturing Practice (GxP) regulations. The ideal candidate will play a key role in ensuring that our products meet the highest quality standards by supporting manufacturing operations and ensuring compliance with regulatory requirements. The role will require a deep understanding of GxP and the ability to drive continuous improvements in quality systems, processes, and product quality. Key Responsibilities: Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements. Develop, implement, and maintain quality engi...

Bachelors degree in information technology, Computer Science, Engineering, or a related field. Minimum 3-5 years of experience in IT administration, preferably within a manufacturing or industrial environment. Strong knowledge of manufacturing IT systems such as MES, ERP, SCADA, PLCs, and industrial network protocols (e.g., OPC, Modbus, Profibus). Strong Knowledge of CSV Qualification documentation. Strong Knowledge of Regulatory guild line like 21CFR11, GAMP5, EU Annex11. Must know about CSV document work flow. Experience with database management, data analytics, and reporting tools. Familiarity with cybersecurity practices relevant to manufacturing environments (e.g., ICS/SCADA security, N...