169 Oq Jobs - Page 7

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards. Responsibilities Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities. Reviewing Product Requirements including Epics, User Stories, and Software Requirements. Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines. Creating realistic test cases and datasets based on real-world customer scenarios. Executing test cases, logging defects, documenting deviations, and reporting test outcomes. Peer reviewing test documentation to ensure quality and adherence to standards. Working collaboratively in a dynamic team environment with open communication. Understanding and adhering to Quality Management System (QMS) standards. Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews. Managing product validation timelines and ensuring quality deliverables. Requirements Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field. At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment. Deep knowledge of the product development life cycle. Understanding of GMP, FDA, and ISO regulations. Proficiency with testing tools and Microsoft Office suite. Self-motivated with a willingness to quickly learn new technologies and products. Excellent interpersonal, writing, communication, and troubleshooting skills. Passionate about testing, validation, and product quality. Able to mentor colleagues and lead small projects efficiently. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

Job Summary: We are looking for a motivated Internal Audit Executive (Fresher) to join our Financial Services Internal Audit team in Bangalore. This role provides an excellent opportunity to start your career in internal audit by supporting audit activities, risk assessments, and compliance checks within the financial services sector. Key Responsibilities: Assist in planning and executing audit assignments under the guidance of senior auditors. Support evaluation of internal controls, risk management processes, and compliance with policies. Conduct data analysis and review financial records and operational processes. Document audit findings and assist in preparing audit reports. Work closely with various business units to understand processes and identify control gaps. Follow-up on audit recommendations and track corrective actions. Maintain audit documentation and ensure compliance with audit standards. Stay updated with regulatory requirements and industry best practices relevant to financial services.

Job Description QA-Qualification Injectable /Parenteral (Officer/Senior Officer/ Executive) Job Location Sanand, Ahmedabad (Injectable Facility) No of Position - 03 Total Experience - 2-7 Years in Injectable Manufacturing Education B. Pharmacy/M. Pharmacy Will appreciate immediate joiner for this role Oversight and Governance QA ensures that all qualification activities (DQ, IQ, OQ, PQ) follow Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., US FDA, EU GMP, WHO). Participates in project planning for qualification activities. Reviews and approves Qualification Master Plan (QMP). Document Review and Approval: QA is responsible for reviewing and approving all qualification documentation: Design Qualification (DQ): Ensures the design of equipment/facility meets regulatory and user requirements. Installation Qualification (IQ): Verifies that equipment and systems are installed as per specifications. Operational Qualification (OQ): Ensures equipment operates within defined parameters. Performance Qualification (PQ): Confirms equipment consistently performs under routine conditions using real products or simulations. Change Control and Deviation Management Evaluates and approves change controls related to equipment or facility qualification. Investigates and approves resolution for deviations arising during qualification. Ensures CAPA (Corrective and Preventive Actions) are effective and documented. Material and Component Qualification : Ensures that raw materials, primary packaging materials (vials, stoppers, syringes), and excipients are qualified and sourced from approved suppliers. Environmental and Utility Qualification Oversees the qualification of: HVAC systems Cleanrooms (classified areas) Water systems (WFI, PW) Compressed gases Ensures compliance with microbiological and particulate limits. Sterility Assurance QA is heavily involved in qualifying systems that ensure sterility: Sterilizers (autoclaves, dry heat ovens) Aseptic filling lines Depyrogenation tunnels Isolators and RABS Data Integrity and Traceability Ensures that qualification activities are well documented. Verifies compliance with data integrity standards (e.g., ALCOA+ principles). Ensures audit trails for electronic systems. Requalification and Periodic Review QA defines and approves the requalification frequency. Monitors ongoing performance trends to determine if requalification is needed. Final Release/Approval QA provides the final sign-off for qualified systems or equipment before they are released for GMP use. Ensures all required documentation is complete, accurate, and archived. Interested candidates are can apply on Darpana: 9978604075 OR can email me on darpana@upman.in

Responsibilities and Duties Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP. Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side. Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5. Coordinate with Client to carry out Validation activity of Computerized Systems and Software. Responsible for achieving & maintaining the validated status of in-scope computerized systems Provide guidance on CSV validation issues and discrepancies Support investigation of CSV defects and quality records (deviation, CAPAs). Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions. Coordinating with teammates in achieving assigned tasks. Issue/bug tracking, and software incident management. Develop and execute test plans to ensure that all objectives are met. Implement and monitor test scripts to assess functionality, reliability, performance, and Coordinate and support to Quality Manager. Ensure that user expectations are met during the testing process Documentation adherence to internal/Client SOP and compliance. Managing department functional process as specified in standard operation procedure & suggest changes if required. Qualifications Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist) Excellent written and verbal communication skills. Proficiency with MS Office tools Documentation management Ability to work as a team player in a consulting environment Knowledge of Computer System Validation. Critical thinker and creative mindset and the ability to approach a problem creatively. A meticulous approach to work. A team player but can work independently too. Multi-tasking and time-management skills, with the ability to prioritize tasks.

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 Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

5+ years of overall experience in SAP technology and consulting experience is required. Data integration, data quality, governance, analytics with products like S/4HANA, PaPM, HANA, BPC etc Minimum 2 years of IT experience with SAP PaPM/FS-PER technologies. Strong experience in SAP PaPM/FS-PER with at least end to end Lifecycle implementation. Knowledge about SAP architecture, processes, and data structures Ability to write test cases, perform testing and resolve defects. Location : Pan India

Role & responsibilities The Deputy Manager - CSV will be responsible for overseeing the validation of computerized systems in manufacturing and laboratory environments, ensuring compliance with regulatory standards and best practices. This role requires strong technical knowledge, attention to detail, and effective communication skills to collaborate with various stakeholders. Desired Candidate Profile : The candidate must have a minimum of 5 years of experience in the pharmaceutical industry, with at least 5 years focused on end-to-end Computerized Systems Validation (CSV) for manufacturing and laboratory equipment. Detail-oriented, with primary responsibilities including authoring in-house CSV documentation and reviewing vendor-provided documents. Experience with software development lifecycle (SDLC) processes, models, and standards relevant to the pharmaceutical industry. Ability to prepare and review end-to-end CSV lifecycle deliverables for manufacturing (HMI, PLC, DCS) and laboratory equipment (e.g., GC-Empower, KF Titrino-Tiamo, UV & FTIR systems, Stability Chambers - ICDAS). Good exposure and hands-on experience with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines and compliance requirements. Proven experience in independently leading validation projects and ensuring compliance in system maintenance activities, including data backup and restoration, user access management, audit trail review, and periodic reviews. Strong oral and written communication skills to facilitate collaboration among site stakeholders. Involvement in Quality Management System (QMS) activities related to computerized systems and engineering as applicable. Knowledge and experience in the validation of Distributed Control Systems (DCS) and Laboratory Information Management Systems (LIMS). Familiarity with preparing risk management processes throughout the lifecycle of computerized systems. Commitment to complying with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, and ensuring the use of Personal Protective Equipment (PPE) where applicable. Preferred Skills: Strong analytical and problem-solving capabilities. Ability to manage multiple projects in a fast-paced environment. Familiarity with continuous improvement initiatives related to computerized systems. Work Location : Piramal Pharma Limited ,Unit 3 , Digwal Village, Kohir Mandal, Dist. - Sangareddy, Telangana

Life Sciences/ Biotech/ Biopharma Validation Specialist Responsibilities: Ensures validation is executed as per the validation plan and/or system change request, and accuracy and quality of data for Q&R fields is maintained in the application inventory management system. Quality Assurance supports, and at times guides, the Business Process Owner, Business Process Expert, and IT team members who are executing the validation activities. Promote high, positive engagement from stakeholders with the process and team. Actively share knowledge and help solve problems with systemic issues driving positive, compliant impact, coaching/mentoring teams as well as assisting in problem-solving for systemic issues. This role will have documented approval actions in multiple deliverables in the QMS application. Perform record reviews to give feedback to authors/application owners. Gather and report data to monitor the validation execution quality and metrics/KPIs. Qualifications A minimum of 5 years, with 7+ years of experience working in a disciplined regulated industry, including validation of computer systems and systems security and control, and in the application of automated technology, particularly 21 CFR, ISO 13485, and GAMP 5. Solid Analytical skills with demonstrated ability to troubleshoot complex process/system issues. Understanding of applicable international and national laws, regulations and standards: FDA (CSV & CSA), ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485/EU MDR and EU Annex 11. Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.• Knowledge and experience in key QMS disciplines (e.g. production and process quality control, design quality control, product risk management, post market surveillance quality control as well as general QMS management) is preferred. High attention to detail. Strong organizational, writing/technical writing, (including clear logic and quality & regulatory compliance documentation approaches, good documentation practices), verbal, and interpersonal skills.

Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology To follow the good manufacturing practices (GMP) . comprehension of DMR translation to production processes. Provides input for Manufacturing requirements in PDLM. To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor. Creates Quality Control Plan and Work Instructions Oversees equipment installation and supports rampup of specific processes at the site Gives input from factory side to the sign-off at SR milestone & project close Implements LCM design changes. Identifies and executes improvements in manufacturing processes, tools and equipment. This for quality and efficiency improvements. Applies lean manufacturing principles. Executes Capex optimization for repeat investments Obtains and installs repeat equipment at the site Initiates production escalations, executes problem solving related to Manufacturing processes, tools and equipment. Accountable for integrity of Masterdata. Identifies and executes improvements in manufacturing processes, tools and equipment. This is for quality and efficiency improvements. Applies lean manufacturing principles. Supports and applies new technologies in factories. Employs equipment, practices, and procedures which promote a healthy, safe, and secure work environment Executes the processes and standards with embedded quality into the way of working including adherence to compliance with safety, Cost regulatory- and environmental requirements as well as local laws, General Business principles and other policies. Initiates and oversees process technology development activities in the context of New Product Generation as well as product and solution technology roadmap. Ensures adherence to the applicable process for product introductions, qualifications and release Responsible for Manufacturing input in PDLM process focusing on DfMAT Initiates and executes Capex optimization for initial investments Is accountable for process and Manufacturing Requirements based on Product Specifications and Test Requirements from I&D Is accountable for the process and equipment capability that meets these Requirements Orchestrates design for lean manufacturing with according to inputs to PDLM workflows. Responsible for PDLM-driven design changes in factories and at suppliers and their implementation Is accountable for MF BOM and routing Master data until release to shipment and for PDLM ruled changes Is accountable for establishing Inspection and Test Criteria for owned components and assemblies Applies lean manufacturing principles To succeed in this role, you should have the following skills and experience. Bachelor’s or master’s degree in production, mechanical, Electrical, Electronics engineering with 8-10 years’ experience. Knowledge of FDA and IEC Standards is a plus. Disciplined team worker, ability to work independently. Ability to present ideas and to convince project team members. Be structured and self-organized. Positive ‘can do’ attitude. Quality mindset in analysis and documentation Excellent communication, both verbal and written Preferably already verification or validation background/ experience Design for 6 sigma / DMAIC is preferred Design for manufacturing, assembly and testability. Understanding special Process like Brazing, Soldering, Cleaning will be added advantage Basic regulatory understanding about ISO 13485, ISO 14971 will be added advantages Supportive in CAPA analysis A background in Data Analytics will be preferred. Integrated Supply Chain Management Capable to solve complex mfg. process Problem. Master data management (system) change Management He/ She should be good at Logistics Fundamentals, Manufacturing Fundamentals, Master data management (system), Operational Excellence, Operational Risk PMI Competencies (Project Management) or Certification will be added advantage Good Knowledge about Procurement & Sourcing Fundamentals Product Innovation & Lifecycle He / She should have good understanding of CAPEX / OPEX Capable to work independently in software tools Windchill, Minitab & SAP. Hands-on experience on performing Process Validations, Test Method Validations and MSA Studies (Process capability studies).

Job Location: Ahmedabad Experience Year : 3-5 Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define a validation strategy based on risk and regulatory impact Documentation: Create and review validation documentation, including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Document test results and deviations. Software Testing as per requirements Internal/ external release. Compliance: Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5). Participate in audits and inspections. Maintain audit trail and data integrity practices. Risk Assessment: Perform risk assessments and impact analyses for changes to validated systems. Change Management: Evaluate system changes and determine need for revalidation. Support Change Control processes. Collaboration: Work with QA, IT, engineering, and business units to support the validation lifecycle. Train users and system owners on compliance requirements. System Lifecycle Support: Manage validation activities through system development, implementation, maintenance, and decommissioning.

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requirements and translate them into scalable digital lab solutions. Ensure data integrity, compliance, and traceability across lab and enterprise systems. Support change management, documentation, and user training for deployed solutions. Qualifications: Bachelors or Masters degree in Information Technology , Life Sciences , Engineering , or Business Administration . Experience in digital lab systems , method development , or scientific IT platforms . Proven experience with BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . Strong understanding of business process modeling , data analysis , and data processing workflows . Familiarity with GxP , 21 CFR Part 11 , and regulated lab environments . Preferred Skills: Experience in pharmaceutical , biotech , or chemical industries. Knowledge of 3DEXPERIENCE , BPM tools , and scientific informatics platforms . Excellent problem-solving, communication, and stakeholder management skills.

Test Lead - Embedded Software Domain: Medical (must have) Location: Bangalore 5 days WFO white field Skill: Experience in qualification of System(computer systems or Analytical instruments). Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR). Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions. Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process. Extensive experience in performing Risk Assessment. Good communication skills and English fluency. Lab equipments knowledge Good to have: Measurement system knowledge Notice Period: 30 Days

Hiring manager and Recruiter should collaborate to create the relevant verbiage. Your Role and Responsibilities Work with Development, Product Management, Security, Support, Legal, Customer Success, and other partners to complete Release Management tasks for software products Coordinate with development and stakeholders to set and manage scope, and to prioritize and schedule release activities Develop release plans, timelines, and milestones, and drive the team to finish tasks on time with high quality Facilitate communication to ensure smooth collaboration across different teams Help fix problemsUnderstand the context, get people talking, get to the bottom of it, get action plans and targets, facilitate retrospective review, and apply learnings the next time Help prevent problemsEducate your stakeholders on the Release Management cycle, creating an informed workforce to improve quality and speed of deliveries Identify and assess potential risks, develop mitigation plans, and take action as needed Facilitate compliance processes such as open source software clearance, security and privacy reviews, and export classification Evaluate and improve release processes based on feedback and post-release analysis Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise 1-5 Years of release management, project management or development management experience Minimum 1 year of overall experience software development and background with the SDLC and GTM requirements Ability to work with architects on technical specification requirements and translate these into execution line items Ability to manage the on-time delivery of feature requirements for all major releases, specifically with Agile methodologies Experience with Triage incoming defects and requirements, and continuously follow up on their progress Experience managing project scrums and prioritizing must fix defects Experience with Project Management and related tools (e.g. GitHub work management and GitHub projects, Jira) Experience with IBM Software Release processes. Experience with AWS and Azure a plus Proficient in Agile methodology with an ability to adapt quickly to changing technology requirements Experience with Agile development principles including sprint and release planning and tracking Expertise at working independently and as part of a team in a fast-paced, dynamic development environment Excellent problem-solving and analytical skills Contribute innovative suggestions for process improvement and automatic Strong organization skills, and strong verbal and written communication skills Preferred technical and professional experience Preferred Technical and Professional Expertise Familiar with software development at IBM (cloud, on-premise or both) Familiar with IBM-specific Release Management, software delivery or compliance Experience with global teams and cross-time zone collaboration

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requirements and translate them into scalable digital lab solutions. Ensure data integrity, compliance, and traceability across lab and enterprise systems. Support change management, documentation, and user training for deployed solutions. Qualifications: Bachelors or Masters degree in Information Technology , Life Sciences , Engineering , or Business Administration . Experience in digital lab systems , method development , or scientific IT platforms . Proven experience with BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . Strong understanding of business process modeling , data analysis , and data processing workflows . Familiarity with GxP , 21 CFR Part 11 , and regulated lab environments . Preferred Skills: Experience in pharmaceutical , biotech , or chemical industries. Knowledge of 3DEXPERIENCE , BPM tools , and scientific informatics platforms . Excellent problem-solving, communication, and stakeholder management skills.

Experience: 2+ years I Industry/ Domain: Fund Administration Apex Group Ltd has an immediate requirement for a FIS Investran Techno-Functional Senior Associate for its Fund Services business within the Private Equity & Real Estate Funds (PERE) division. The principal responsibilities for the job are managing client reporting request, monitoring the Investran database, enhancing the technical product and supporting operational excellence. . The role requires. Design, develop and implement high quality reports for our global Private Equity clients and their investors. Knowledge of PE GL Suite FIS Investran is a must. Promote product knowledge and team initiatives key PE forums such as the Investran Task Force. Understanding any manual process and work on automation improvements. Work on ad-hoc projects driven by the business while continuing to support the day-to-day requirements. Create and maintain technical documentation, including user manuals and guides. Desired Technical Experience and Knowledge: 3+ years of related experience with Crystal Reports & SSRS Report Builder is a must Writing SQL queries against any RDBMS, VBA and other Programming language will be a plus Good understanding of unit testing, software change management, and software release management Domain/Working knowledge of financial industry data models is a plus. General knowledge/skills: Databases, Excel, PowerPoint Position Requirements Include: BE plus/or Post-graduate / CFA / CA / MBA / CCRA / CIIA / CAIA & equivalent 2+ years of experience in relevant fund admin experience incl. Client Reporting and Application support Strong research and analytical skills, including critical thinking and the ability to integrate various sorts of data and information in the analysis Experience working independently, proactively identifying or initiating ways to enhance a process, procedure or outcome that benefits the organization Ability to prioritize a large and varied workload, managing multiple tasks and details simultaneously Ability to show initiative, willingness to learn and take on responsibilities as contributing team member either in a lead or in a backup role to ensure team success Should be solutions focused and have the ability to work in unstructured environments under minimum or no supervision Willingness to acknowledge what is not understood and seek assistance Effective oral and written communication skills to clearly articulate analysis Advanced understanding of MS Excel, Word and PowerPoint.

Job Responsibilities Handle and perform floor level activities of secondary packaging to complete the packaging jobs within defined timelines and with the desired quality standards. Ensure that all team members technically adhere to the defined SOPs and GMP guidelines. Prepare and maintain all records and documents as per SOPs, ensuring team compliance. Support the packaging manager in change part development and the preparation, review, and implementation of SOPs. Perform FAT, IQ, OQ, PQ of equipment and prepare the necessary documentation. Operate GPMS systems to complete EBR jobs and train personnel. Face Client, Regulatory, and Internal audits successfully. Ensure that all machines and equipment in the packaging area are maintained as per desired standards. Provide operational training to new team members on SOPs and packaging activities. Lead routine activities at the floor level, seeking mentorship from the manager as needed. Support the packaging manager in preparing and reviewing functional SOPs and documents. Prepare daily, weekly, and monthly reports as required. Collaborate cross-functionally with client service departments. Support project manager for FCS label printing activities and coordinate with project teams and vendors. Plan, coordinate, complete, and report on project-related FCS label printing activities. Lead technical projects regarding software for handling the generation, printing, and inspection of clinical labels using Clinical labeling software. Qualifications B. Pharm / M.Sc.: Minimum 3 years of experience in Pharmaceutical Packaging. B.Sc. (Science): Minimum 5 years of experience in Pharmaceutical Packaging. Skills, Knowledge, and Experience Understanding of GMP and Schedule M. Knowledge of Computer Systems and GMP Documentation. Experience in handling GMP investigations. Basic knowledge of Equipment qualification. Proven team handling skills. Apply Link - https://jobs.thermofisher.com/global/en/job/R-01320330/Sr-Packaging-Labeling-Technician