Computer System validation Expert

2 weeks ago


delhi, India CO-WORKER TECHNOLOGY AB Full time
Computer System Validation Expert
Requirements:
Pharma application areas: Clinical domain, Pharmacovigilance domain and Manufacturing domain ( PV/Argus, CTMS applications, SaaS platform, AWS, manufacturing. QMS)
Experience level :
Validation team – 5 years plus
Responsibilities:
Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient, and integrated CSV program.
Perform System Risk Assessment
Create the end-to-end Validation Plan/Strategy
Review Requirement Specifications including Regulatory & non-functional requirements.
Review the Technical Design document and solution architecture.
Perform Requirement Risk Assessment
Author Test Plan
Review Pre-executed and post executed IQ, OQ and PQ Scripts
Review IQ/OQ/PQ Summary & Traceability Matrix
Create Validation Summary Report
Manage Change Controls
Perform Periodic Review and manage CAPA
Provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.
Qualifications:
Bachelor's/master’s degree in engineering, Science, Medical or related field.
Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.
A minimum of 5-10 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).
Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge.
Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions.
Preferred:
Automation: Technical and understands GenAI, automate authoring process, reduction of 20% effort. Standard validation template, generate a plan. Providing more value.
Contact: Rekha Poudyal
Ready for your next career move? Explore opportunities at co-workertech.com

  • Delhi, India PSC Biotech Full time

    Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a...


  • Delhi, India PSC Biotech Full time

    Job DescriptionThe Computer Systems Validation Engineer (CSV) will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible and...


  • delhi, India Chara Technologies Full time

    At Chara Technologies ( we are building revolutionary cloud-connectedelectric motors for scalable deployment in various applications ranging from Electric Vehicles toUnmanned Aerial Vehicles. We design and develop the hardware and software that drives thesemotors. The founders are veteran serial entrepreneurs, product experts, and motor technologists...


  • Delhi, India RMP ITlorist Technologies Full time

    Conduct risk & impact assessment to determine the extent of validation and qualification - Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems - Implementation of organizational IT controls in accordance with applicable regulations and the...

  • Validation Expert

    1 month ago


    Delhi, India PeopleLogic Business Solutions Full time

    **We are hiring for an Indian multinational information technology (IT) services and consulting company.** **Must-Have*** **(Ideally should not be** **more than 3-5) ** Understand business requirements and provide consultancy on Validation Strategy with good communication skills to interact with German customer * Should be able to understand Business...


  • Delhi, India Awign Expert Full time

    Job DescriptionAbout Awign Expert:Awign Expert is an Enterprise focused platform that helps businesses Hire, Assess and Manage high skilled resources for Gig Based Projects. We provide our Experts a gateway to work for and build a freelance/consulting career with large scale Enterprises. We are a newly launched business division of Awign, which is one of the...

  • Validation Manager

    2 weeks ago


    Delhi, India Next-Link Full time

    Job DescriptionWe are seeking a highly motivated and experienced Validation Manager to join our team, providing expert services to a leading pharmaceutical client.Main tasks and responsibilities:Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.).Define and implement...

  • Java Developer

    5 days ago


    Delhi, India Awign Expert Full time

    Job DescriptionAbout Awign Expert :Awign Expert is an Enterprise focused platform that helps businesses Hire, Assess and Manage high skilled resources for Gig Based Projects. We provide our Experts a gateway to work for and build a freelance/consulting career with large scale Enterprises. We are a newly launched business division of Awign, which is one of...

  • Computer Faculty

    1 month ago


    Delhi, Delhi, India ACS SYSTEM SOLUTIONS Full time

    **Job responsibilities**: - Basic to Advance computer knowledge. - Passionate about fostering computer literacy and academic excellence. - Bachelor’s degree in a computer-related field. - Plan and administer a curriculum that prepares students for careers in Information Technology, including personal computer hardware and software, operating systems,...

  • Computer Faculty

    1 month ago


    Delhi, Delhi, India ACS SYSTEM SOLUTIONS Full time

    **Job responsibilities**: - Basic to Advance computer knowledge. - Passionate about fostering computer literacy and academic excellence. - Bachelor’s degree in a computer-related field. - Plan and administer a curriculum that prepares students for careers in Information Technology, including personal computer hardware and software, operating systems,...

  • Ai Expert

    1 week ago


    Delhi, India Lotus Interworks Full time

    Job Title: AI Expert REMOTE 7pm IST to 4am IST (US SHIFT) Position Overview: The AI Expert will be responsible for leading and contributing to cutting-edge projects in artificial intelligence, machine learning, and related fields. This role offers an exciting opportunity to work on challenging problems, develop innovative solutions, and make a significant...


  • Delhi, India Optellix Private Limited Full time

    As an Automotive Lighting Validation Consultant specializing in Ansys Speos, you‘ll play a pivotal role in developing this industry-leading product, renowned for its prowess in designing and simulating automotive lighting systems. Working alongside accomplished experts in automotive lighting, you‘ll contribute to the refinement and enhancement of Ansys...

  • AI Expert

    3 weeks ago


    delhi, India Lotus Interworks Full time

    Job Title: AI ExpertREMOTE7pm IST to 4am IST (US SHIFT)Position Overview: The AI Expert will be responsible for leading and contributing to cutting-edge projects in artificial intelligence, machine learning, and related fields. This role offers an exciting opportunity to work on challenging problems, develop innovative solutions, and make a significant...


  • Delhi, India Wipro Full time

    Location:Pune/BangaloreExp:7-10YJob Description:Bachelor of Science in Computer Science, Computer Engineering, Electrical Engineering, or other related fieldsdegree in computer science, Computer Engineering, Electrical Engineering, or other related fields preferredleast 7 years of automotive system and component verification and validation experienceyears of...

  • Subject Matter Expert

    1 month ago


    Delhi, India The expert community Full time

    **Responsibilities and Duties** - Prepares instruction that reflects appropriate learning objectives - Constructs classroom materials that support the goals of the course - Instructs and guides the class in an energetic, efficient, and effective manner - Develops a schedule of instruction - Remains up-to-date on technology and methods of teaching with...

  • Computer Technician

    1 month ago


    New Delhi, India Ecorel Computer Systems Pvt. Ltd Full time

    We are looking for a qualified Computer Technician to install, maintain and repair computers and networks. You will be the one to ensure that adequate IT infrastructure is in place and is used to its maximum capabilities. As a computer technician you must be well-versed in computer systems and network functions. The ideal candidate will be able to work...

  • Virtualisation SME

    4 weeks ago


    Delhi, India Awign Expert Full time

    Job DescriptionAbout Awign Expert:Awign Expert is an Enterprise focused platform that helps businesses Hire, Assess and Manage high skilled resources for Gig Based Projects. We provide our Experts a gateway to work for and build a freelance/consulting career with large scale Enterprises. We are a newly launched business division of Awign, which is one of the...

  • Computer Technician

    1 month ago


    New Delhi, India Ecorel Computer Systems Pvt. Ltd Full time

    At Ecorel Computer Systems Pvt. Ltd, we are currently seeking a skilled and experienced Computer Technician to join our team. As a Computer Technician, you will be responsible for installing, maintaining, and repairing computers and networks for our clients. Your primary goal will be to ensure that all IT infrastructure is in place and functioning properly...

  • Validation Engineer

    3 days ago


    delhi, India IPS-Integrated Project Services Full time

    Looking for a candidate with Good Knowledge in Bio-Pharmaceutical manufacturing Processes and the Process equipment for OSD/Sterile/Creams/Ointment manufacturing, API manufacturing/High Potent compound manufacturing (Product/Personnel/facility Containment requirement) and facility design requirement.Should be able to conduct Quality Audits, Gap Analysis of...

  • Java Developer

    1 month ago


    Delhi, India Awign Expert Full time

    Job DescriptionAbout Awign Expert:Awign Expert is an Enterprise focused platform that helps businesses Hire, Assess and Manage high skilled resources for Gig Based Projects. We provide our Experts a gateway to work for and build a freelance/consulting career with large scale EnterprisesWe are a newly launched business division of Awign, which is one of the...