99 Gamp Jobs - Page 4

Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance. Lead and manage the QA aspects of IT system validation activities, including document review, filing, system uploads, and approvals, ensuring compliance with relevant regulations (e.g., GCP). Maintain QA databases and electronic file systems related to IT system validation, change control, and audit trails. Oversee and maintain the IT system inventory list, ensuring accuracy and completeness of all documented systems. Independently manage the IT system change control process, including review, assessment, and approval of changes to validated systems. Provide expert advice, interpretation, and training on CSV requirements, GAMP 5 principles, and relevant regulatory guidelines Create, update and collect SOPs, templates and forms/documents. Participate in and contribute to the review and follow-up of corrective and preventive action plans (CAPAs) arising from IT system audits, deviations, and regulatory inspections. Support the Quality Assurance team in the coordination of internal and external audits, including readiness activities specific to IT systems and CSV. Assist in audit preparing activities such as Quality Assurance Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments Track and ensure compliance with timelines for IT-related quality activities, including system reviews, approvals, and training Support cross-functional teams (e.g., IT, Data Management) in ensuring the quality and compliance of computerized systems throughout their lifecycle. Manage the end-to-end process for training within the Learning Management System (LMS), including creation, assignment, and disabling of training. Contribute to the development and monitoring of Quality Key Performance Indicators (KPIs) related to IT system compliance and identify areas for improvement. Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance. Assist the Quality Assurance Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc. Any other reasonable task that derives from the previous ones or the position requires.

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 overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagement within the team Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills Mandatory Skills: SAP FS-CM Functional. Experience8-10 Years.

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge on Computer system Assurance (CSA) Experience in the validation of software and tools in a FDA regulated environment. (e.g, SAP, Solution Manager, EDMS, LIMS, PLC/SCADA systems etc.) Good to have experience on infrastructure qualification documentation- QP, IS, IQ, RTM Basic understanding of cyber security, Public Cloud Platforms such as AWS, Azure, IT Network components is a plus point. Experience of authoring and reviewing validation documentation and SOPs to maintain compliance Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies as per cGxP Experience in risk assessment during the implementation and operation of IT solutions. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and SOPs. Review the accuracy and completeness of software validation deliverables created by other process teams CSV deliverables like of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like SOPs, Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols for accuracy, consistency, clarity, and completeness Understand Deviation, how to perform its investigation and propose CAPA for the deviation. Handled change management and aware of writing change requests. Experienced in working with validation tools such as HP ALM/Validator/Valgenesis Ability to lead projects end-to-end, including stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible. Experience in facing internal quality audits, vendor audits and also providing support during audits by external auditors like US FDA in validation perspective. Mandatory Skills 21 CFR part 11, EU Annex 11, GAMP MS Office Suite- Word, Excel, PowerPoint Good verbal, and written communication skills in English Good to have Knowledge of 21 CFR Part 210, 211, 820, EU MDR, SOX, CSA Certifications such as ISO 27001, Cloud certification, Testing ISTQB, TMMi Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.

About The Role 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 overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. ? Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagement within the team ? Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills ? Mandatory Skills: SAP FS-CM Functional. Experience5-8 Years. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. ? Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines. ? Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. ? Ensure timely and effective completion of all validation activities in line with project objectives and schedules. ? Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. ? Identify opportunities for process improvements in validation activities. ? Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies. ? Collaborate and communicate effectively with the product teams. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and teamwork skills Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Work with us We are looking for a determined and dedicated Advanced Engineer for ProcessAutomation who can provide innovative solutions in complete life science andpharmaceutical projects. This also includes understanding the clients complexprocess facilities, with Good Automated Manufacturing Practice (GAMP) regulatedrequirements for a pharmaceutical production facility. Our department consistsof dedicated engineers, specialized in different phases of the project includingConceptual Design, Basic Design, Detailed Design, Commissioning andQualification. How you might spend your days As an AdvancedEngineer for Process Automation, you'll be working with a motivated, multi-functionalteam where youll be: Responsible for deliverables where output is Medium to Complex in a specific area such as: Development of functional specifications / design documents. DCS Application coding based on programming standards and design guidelines. Peer reviews to ensure consistency. Co-ordination and alignment with cross-functional teams i.e. Process/Mech. & E/I Team Testing and Verification to ensure that programming or coding is meeting functionality. Commissioning and Qualification to ensure that systems and equipment meet the requirements of end-users and regulatory agencies with multi-discipline collaboration. Assisting lead/Sr. colleague on different tasks based on project phase. Contributing to technical solution within/across team. Demonstrating Subject Matter Expertise in a specific area. Sharing lessons learnt / guiding juniors. We offer you aposition where you will interact with highly skilled engineers withinAutomation in an active and exciting environment that allows you to continuegrowing with new ways of working at NNE. You will work in a project-oriented,international climate supporting our customers and colleagues across the globe.Our projects cover the full range from small revamp projects to high-volumegreenfield production facilities. NNE handles projects for a vast number ofinternational customers and intends to continue expanding our business abroad.Consequently, you may expect travelling activities of shorter or longerduration. We do not expectyou to know it all, as we ourselves need to develop and be open-minded toconstantly find the right solutions. We are ready to welcome our newcolleague(s) with a professional onboarding program and internal courses andtraining that keep our biggest asset you developed for the long run. Who you are At NNE,we care about who you are as a person. In the end, how you work, and yourenergy is what impacts the work we do as a team. As a person, you are: Able to perform work independently. Able to adapt procedures, processes, tools, equipment, or techniques to accomplish the correct output of specific assigned tasks. Able to take initiative, prioritize, and plan the work to reach deadlines. Able to make operational decisions through a choice between known alternatives. Having a positive approach and can be persistent when facing challenges. Customer-oriented and focused with strong professional ethics. Excellent in communication skills and open-minded to learn new things. The miles youve walked. To applyfor the position there are some things that are needed, and others are a bonus.We believe these qualifications are needed for you to do well in this role: Have a degree in engineering in Electronics/Instrumentation/ Electrical/Industrial Automation or similar technical field. You have at least a minimum experience of 5 years in a similar field Good working knowledge of 800xA system (Control Builder , Hardware/Software), other system libraries or any other DCS automation systems. Knowledge of PCDL, PCEL libraries and SFCs would be an added advantage. Good understanding of Process Automation System Architecture, ISA S88 Batch, pharma process, good engineering practice, GDP & regulatory knowledge would be preferable. Knowledge of Design/ functional specifications (Control Module, EM and Phase class) & application development for recipes would be preferable. Experience in Integration Specs, Installation packages, Test and Qualification protocols including test plans would be preferable. FAT, SAT, IQ and OQ experience would be preferable.

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.

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, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.

Role Responsibilities Support and improve the performance and maintainability of automation systems already in the field. Troubleshoot complex issues involving PLC, SCADA, and HMI systems, and drive root cause investigations. Collaborate with service and support teams to resolve customer-reported issues and develop effective solutions. Provide coaching and technical documentation to support junior engineers and cross-functional teams. Contribute to product documentation and ensure compliance with GMP, GAMP, FDA, and other regulatory standards. Participate in automation system improvements, contributing ideas to enhance standardization, modularity, and usability. Minimum Qualifications Bachelors degree in Automation, Industrial Engineering, or equivalent through experience. At least 8 years of experience in a highly regulated industry such as biotech, pharma, food, or chemicals. Proficient in PLC programming (preferably Siemens TIA Portal) and SCADA systems such as Wonderware Archestra. Strong critical thinking and problem-solving skills, with clear communication and a collaborative approach. Preferred Qualifications Experience working with commercialized automation products in a life cycle management context. Familiarity with quality systems and cross-functional collaboration in regulated environments. An understanding of industrial electricity and instrumentation.

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.

Job Summary: We are seeking a highly skilled and detail-oriented Computer System Validation (CSV) Consultant with proven experience in validating SAP systems (SAP ECC, SAP S/4HANA, SAP GxP modules, etc.) within regulated environments such as the pharmaceutical, biotechnology, or life sciences industries . The ideal candidate will be responsible for ensuring SAP systems are compliant with GxP regulations, 21 CFR Part 11, Annex 11 , and other applicable standards by leading and executing validation activities throughout the system lifecycle. Key Responsibilities: Lead and perform CSV activities for SAP systems, including validation planning, risk assessments, and test script development (IQ/OQ/PQ). Execute validation tasks and compile comprehensive documentation including Validation Master Plans (VMP), URS, FDS, RTM, test scripts , and Validation Summary Reports (VSR) . Ensure adherence to GAMP 5 , FDA 21 CFR Part 11 , EU Annex 11 , and internal quality standards. Collaborate with cross-functional teams (IT, QA, Business) to understand system configurations, user requirements, and assess the validation impact of system changes. Perform impact assessments for SAP enhancements, upgrades, patches, and new implementations. Support periodic reviews , change control , CAPA , and audit readiness activities for validated SAP environments. Provide GxP validation expertise for SAP modules such as MM, PP, QM, WM, ATTP, PM , and integrated systems such as LIMS , MES , etc. Required Skills & Qualifications: Bachelors or masters degree in Life Sciences, Pharmacy, Computer Science , or a related discipline. 3+ years of experience in Computer System Validation , with a minimum of 2+ years in SAP system validation . Strong hands-on experience with SAP ECC or SAP S/4HANA in a GxP-regulated environment. Expertise in GAMP 5 , 21 CFR Part 11 , and Annex 11 compliance frameworks. Proficiency in developing and reviewing validation documentation across the lifecycle. Excellent communication skills with a proven ability to coordinate across teams and stakeholders.

Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook and PI Vision Hands on experience in implementing, configuring and troubleshooting of OSI PI Interfaces including, but not limited to, OPC DA, PItoPI, RDBMS and UFL and has successfully implemented within several client projects. Good understanding of standards & protocols like ISA S88, ISA S95, OPC etc. Excellent working knowledge of OSI PI systems, including functional and technical features as well as limitations of OSI PI Product suite Responsibilities : IT-OT integrations including Industrial Connectors such as Kepware. Mentors System Analysts and can provide UAT & Validation support. Ability to work with all levels of the organization, both technical and non-technical. Good knowledge in Computerized System Validation, GAMP, GxP environments, Quality Systems. PI Data Access Methodologies AF SDK, OLEDB/ODBC/JDBC Provider, PI OPC DA/HDA Server, PI Web API Willingness to learn special and new technologies (Edge technologies and IoT). Experience and desire to work in a Global delivery environment. Level 100 & Level 200 Accredited preferred

Job Title: Senior IT Administrator Bioanalytical Support Experience: 3-5 Years Job Summary: The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems. Infrastructure & System Support Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems. Administer Windows Server environments, Active Directory, Group Policies, and file/print services. Ensure uptime and performance of systems supporting LC-MS/MS, HPLC, and other analytical instruments. GxP & Compliance Ensure IT systems supporting bioanalytical operations meet GxP, GLP, and FDA 21 CFR Part 11 compliance requirements. Support audits and inspections by providing IT-related documentation, access logs, validation records, and system controls. Assist in Computer System Validation (CSV) and Data Integrity initiatives as per ALCOA+ principles. Application & Lab Systems Support Provide L2/L3 support for laboratory applications such as LIMS , Analyst , Thermo , LabSolutions , or equivalent. Coordinate with instrument vendors and internal QA/RA for software upgrades, patches, and validation. Manage user access and security configurations for lab applications and instruments. Data & Backup Management Oversee automated and manual backup processes for lab-generated data, ensuring integrity and retrievability. Ensure secure, compliant storage of analytical and raw data per regulatory retention policies. User & IT Operations Support Act as the primary IT point of contact for lab users and scientific staff. Troubleshoot lab connectivity, software, printing, and data access issues. Provide training and guidance on compliant IT practices within lab operations. Documentation & Change Control Create and maintain SOPs, user guides, validation protocols, and IT system documentation. Participate in Change Control, Deviation, and CAPA processes involving IT systems. Key Skills & Competencies: Strong understanding of bioanalytical workflows and regulated lab environments. Hands-on expertise in Windows OS, Active Directory, networking, data backup, and IT security. Experience supporting regulated lab software (LIMS, chromatography systems) . Familiarity with Computer System Validation (CSV) , GAMP 5 , and data integrity concepts. Good problem-solving and communication skills. Ability to work under audit-ready, regulated environments.

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.

Sikich is seeking an experienced Validation Analyst to join our dynamic team and contribute to our commitment to quality and compliance in the field of computer systems validation. Primary Job Responsibilities: Develop/design OQ, PQ scripts along with RTM mapping Perform dry run, formal execution and Issue re-testing Maintain constant communication with management and peers Create FRS, Validation plans, if required Create any training repository and leveraging existing team's knowledge Provide value adds to the project/organizations Requirements: Must Have Experience: Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP Experience in electronic / paper-based execution methods TrackWise / Veeva QMS and HP ALM tool knowledge will be an added advantage At least one year of experience in Life sciences domain and CSV Must Have Life Skills: Ability to multitask by handling more than one client project at the same time Excellent Analytical and problem-solving skills Proven understanding of existing project Must be Self-driven as well as ability to learn, provide solutions both independently and with team is essential Good communication ability and technical presentation ability (oral and written) Technologies / Domain: TrackWise is an added advantage Knowledge of Scripting Nice to Have: Knowledge of the Agile methodology and experience working on a scrum team Benefits of being a part of the team Family Health Insurance including parents Life & Accident Insurance Maternity/paternity leave Performance-based incentives Referral Bonus program Exam Fee Reimbursement Policy Indian festival holidays 5 days working week Doctor's Consultation

Role & responsibilities Monitoring Backup jobs training the documentation, and keeping to IT Head approval. Responsible for tracking hardware and software inventory in the ticketing tool. Updating the IT assets Maintaining the labels for all IT assets. Responsible for the Backup Responsible for GMP-related queries and prepared the documentation IT-related bills are filed and kept for approval. PCB-related onsite support and coordinating with vendors supported by the reporting Head. Monitoring and maintaining the CC Cameras infrastructure and escalating to the head if anything is critical. Troubleshooting third-party applications at the Unit level and escalating to the reporting Head to get solutions from 3rd party vendors. Technical Support on Enterprise resource planning (ERP/FOCUS) to End users through (Ticket, Mail, Mobile, and Remote) in Sipra has the following modules: Accounts, Purchase, Sales, Inventory, and Payroll. Conduct training sessions for new and existing users for any developments supported by the IT Head. Knowledge on complete Desktop and Server support. Configuring servers using 2003, 2008,2012, 2016 and 2019. Knowledge on Active Directory services, Installing active directory-Domain controller, group policies and adding Client machines in to AD User administration i.e., setting up user accounts, permissions and passwords Knowledge on remote technical assistance Software installations and configurations. Establishing LAN, adding / removing nodes to / from LAN Working knowledge of MS Active Directory 2012 and 2016 Knowledge on DNS, DHCP & FTP Knowledge on firewalls, routers and switches(Cisco, WatchGuard) Giving complete technical support to all virus-related issues and network related issues Managing email, anti-spam and virus protection. Preferred candidate profile Pharma Experience is must for the candidate. Should have basic understanding for 21CFR and GXP Systems

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

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.

India's marquee global technology company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the IT product and service industries. They are a respected career company and a long-term wealth creator. Location: Hyderabad/Bangalore/Chennai/Pune/Mumbai/Delhi/NCR/Kolkata Purpose of the role & key responsibilities: Lead project compliance work streams, responsible for end to end quality and compliance aspect of the project, validation deliverables, client buy-in and reporting leading to successful project delivery and client delight Engage with key stakeholders for execution of day-to-day interactions with client teams Participate in practice development activities Strong business consulting and excellent soft skills Demonstrates proven success in roles and thorough abilities in one or more of the areas. Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5 and SOX IT Subject matter expertise in areas such as Quality Management, document management and Change Management Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry Working knowledge of Risk Management, periodic or control maturity assessment and Audits Must have global client exposure and have worked in Global delivery model Your Profile 5-15 years of computer System validation experience in Life Sciences industry working for a consulting services organization and/or industry experience. Bachelors /Master degree, preferably in pharmaceutical sciences or related field.