[Immediate Start] Validation Lead

3 weeks ago


Delhi, India CO-WORKER TECHNOLOGY AB Full time
Job Role: Computer System Validation Lead

Location: Pune, India

Job Type: On-Site

Long term program: 18 months

Work Experience: 7-10 years

Validation Requirements:

US West Coast Customer, overlap for first half of the day in the US, Another client is Europe based.

Working hours:

VL: 12 noon – 9 pm IST (Validation Lead )

Requirements:

Pharma application areas: Clinical domain - PV/Argus, CTMS applications, SaaS platform, AWS, manufacturing. QMS

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.

Apply Or Share your Cv at:

Ikra Fatima

Empower your career with us Discover openings at co-workertech.com
  • Validation Lead

    2 weeks ago


    delhi, India Livspace Full time

    DescriptionA Validation Lead offers solutions on both modular and services scope of work. While modulars are handled by our dedicated vendors across the country, services are delivered through a curated marketplace of Livspace-certified contractor partners and an in-house contracting team. To ensure we are providing the right inputs to our vendor partners...


  • 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...

  • 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...


  • Delhi, India Yuma Energy Full time

    Yuma Energy is a leading Battery as a Service (BaaS) provider offering battery swapping for 2 & 3 wheelers currently operating 150+ locations and 5 cities with an ambition to grow our network to be the largest in the country in the coming years.As a Director of Charging Systems, you will be responsible for building and leading a team in end-end engineering...


  • Delhi, India COX-LITTLE & COMPANY Full time

    UKG Ready Support Consultant (Offshore)Remote - IndiaImmediate StartEducation: Bachelors required or equivalentRequired Skills:- 6+ years of technical support experience with Kronos/UKG Ready- Technical knowledge in Payroll, Talent Management, HR and scheduling with UKG or Kronos Ready- Implementation or Upgrade experience preferred- 3+ years of a Kronos...


  • Delhi, India Dexian Full time

    Job Role: ERP Coordinator(PeopleSoft Financials and Supply Chain Management consultant)Work Mode: RemoteExperience range: 4 – 7yrs.Role Description- A Technical Consultant with good understanding of PeopleSoft application and technologies- Be a part of the larger group focusing on technology transformation as a representative of PeopleSoft FSCM application...


  • Delhi, India Hetero Full time

    DescriptionWe are seeking a seasoned Lead Role of Learning & Development in Jadcherla will lead the training and development initiatives, utilizing their 8-12 years of experience and expertise in Learning Management Systems. Responsibilities include designing and implementing training programs, fostering a culture of continuous improvement, and enhancing...

  • 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...

  • Validation Engineer

    15 hours 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...


  • delhi, India SUN Mobility Full time

    ABOUT SUNMOBILITYWelcome to SUN Mobility, where we aim to make electric vehicles affordable and accessible to all.At SUN Mobility, we believe electric vehicles are the future of mobility, and we aim to accelerate the adoption of electric mobility with our innovative battery swapping technology. Our technology is designed to be universally interoperable...


  • Delhi, India SUN Mobility Full time

    ABOUT SUNMOBILITYWelcome to SUN Mobility, where we aim to make electric vehicles affordable and accessible to all.At SUN Mobility, we believe electric vehicles are the future of mobility, and we aim to accelerate the adoption of electric mobility with our innovative battery swapping technology. Our technology is designed to be universally interoperable...


  • Delhi, India GyanSys Inc. Full time

    Experience : 8+ yrsNotice Period : Immediate - 15 daysLocation : Remote- Experience working with SAP MDG Material, Business Partner, Supplier master data objects- Lead key data management and governance principles of SAP S/4HANA MDG architecture, functionality, and configuration- Lead SAP MDG configuration and business mapping in Data Modeling, UI Modeling,...


  • Delhi, India Focus Edumatics Pvt Ltd Full time

    We are seeking a highly skilled and experienced QA Data Engineer to join our “Global Insights & Analytics” team.. As the QA Data Engineer, you will play a crucial role in ensuring the quality and reliability of our data across all systems.. In this position, you will collaborate closely with other stakeholders across different functions to develop and...


  • New Delhi, India IndiaIT360 Full time

    We are currently looking for “Business Head” for our Delhi/ Noida location.Employment Type: Full TimeJob Position: Business HeadJob Location: New Delhi/NoidaNo. of Opening: 1About UsIndiaIT360 ( is a B2B Digital platform which is part of the Unistal Group( connects all the stakeholders of the ICT industry starting from OEMs, Startups,...


  • 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...


  • Delhi, India Pierian Services Full time

    Role: Import & Export ExecutiveLocation: BidadiExperience: 1-4 yearsNotice period: Immediate to 30 daysJOB DESCRIPTION:- Import Purchase order creation (Basic trading knowledge an advantage)- Import Document Check (Import Process know-how an advantage)- Coordinate Custom clearances (with CHA/ Port / Importer etc)- Database management – Excel- Payment...


  • Delhi, India Quess IT Staffing Full time

    Dear All,We are Having Openings Senior Disaster Recovery Coordinator for one of our client in Pune location.Payroll : QuessExperience : 10+ YearsLocation : PuneWork Mode : HybridInterview Mode : VirtualNotice period : Immediate Joiner or 15 daysSkills : Leading Disaster Recovery, Develop Disaster Recovery plans, Risk Assessment, DR TestingInterested...


  • New 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...

  • Mainframe Developer

    3 weeks ago


    Delhi, India Recro Full time

    Job Title: Lead/Senior Mainframe Developer/ConsultantLocation: Bengaluru, Karnataka, IndiaExperience: 4-8 yearsWe are seeking a dedicated Mainframe Developer to join our IT department. The ideal candidate will be responsible for managing, maintaining, and supporting mainframe applications. This role involves a variety of tasks including production support,...


  • Delhi, India CES Full time

    About the job:CES has 26+ years of experience in delivering Software Product Development, Quality Engineering, and Digital Transformation Consulting Services to Global SMEs & Large Enterprises. CES has been delivering services to some of the leading Fortune 500 Companies including Automotive, AgTech, Bio Science, EdTech, FinTech, Manufacturing, Online...