Senior Quality and Computer Systems Validation

3 weeks ago


thrissur, India SecureGen Full time

Job Description

SecureGen is seeking a Senior Quality and Computer System Validation (CSV) Associate that provides quality and compliance oversight for GxP computerized systems across SecureGen internal and pharma clients hosted implementations. In this role you will be responsible for assuring that GxP systems are validated in compliance with current regulations and SecureGen’s risk-based computer system validation procedures. Must have data integrity, computer system validation, change management, risk management, issue management and software development lifecycle knowledge.


Responsibilities

  • Lead all quality initiatives for both internal and client hosted computer system implementations as a Computer System Validation Domain Process Owner
  • Drive strategy and direction of the development of standards and procedures and aligning with key partners on implementation of validation requirements.
  • Provide guidance on and interpretation of GxP guidance and regulations of computerized systems, electronic records, electronic signatures and data integrity requirements (21 CFR Part 11, EU Annex 11).
  • Provide computer system validation quality assurance oversight for computerized systems used in Drug Development clinical functional areas including - Data Sciences, Biomarkers and Clinical Pharmacology.
  • Provide guidance for the implementation and validation of computerized systems, including the review and approval of validation deliverables and change controls.
  • Supervise quality initiatives, including fostering a commitment to Quality in individuals and a culture of quality within SecureGen.

 

Qualifications

  • Bachelor’s degree with 5+ years of experience with implementing and validating regulated clinical systems
  • Extensive understanding of GAMP 5, SDLC, ICH guidelines, 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems including good documentation practices.
  • Exceptional verbal, written, interpersonal, organizational and project management skills.
  • Excellent organizational and project management skills.
  • Able to lead and mentor junior/senior staff and cross functional teams.


  • Thrissur, Kerala, India Vodafone Idea Limited Full time

    We are seeking a Senior Software Engineer with a strong background in High-Performance Computing. The ideal candidate will have a deep understanding of computer systems and a passion for developing efficient and scalable software solutions.Responsibilities include:Designing and implementing high-performance computing systemsCollaborating with...


  • Thrissur, Kerala, India RCOR Full time

    Job Summary: We are seeking a highly skilled Sys-tems Analyst to join our team at RCOR. The ideal candidate will have a strong background in computer science and software development, with excellent analytical and problem-solving skills.Key Responsibilities:Research and recommend technologies, systems, and solutions to meet customer requirements.Design and...


  • Thrissur, Kerala, India BrightEdge Full time

    About BrightedgeBrightedge is a fast-growing technology company that empowers businesses with innovative software solutions. Our team is dedicated to delivering high-quality products and services that enhance our clients' performance and productivity.Job DescriptionWe are seeking a Senior Quality Assurance Engineer with over 8 years of experience in quality...


  • Thrissur, India Valeo Full time

    Analyze the Component requirements● Analyze the stakeholders needs (Customer and Valeo)● Elicitate requirement with the stakeholders● Define the functional and non functional Component requirements● Identify the system functions and allocate requirements per functions● Uses modeling and simulation techniques for ensuring correct requirement...

  • Systems Analyst

    2 weeks ago


    Thrissur, India RCOR Full time

    Working close with the Product Development arm of RCOR, to research and recommend technologies, systems and so on, based on the customer requirements. The focus at the moment, is around our Data Processing solutions and services area. This would move out to other solution areas subsequently. The job profile would require an individual with good development...


  • Thrissur, India R.S. Industries Full time

    Company DescriptionR.S. Industries, Polytuf is a trusted manufacturer and supplier of PTMT Bathroom Accessories & Hardware Fittings under the brand name POLYTUF® in Delhi, India. The company's core values include high quality at sensible rates, with a focus on customer satisfaction. With over 30 years of experience, R.S. Industries supplies products to...


  • Thrissur, Kerala, India RCOR Full time

    Job DescriptionAt RCOR, we are seeking a skilled Technical Systems Specialist to join our Product Development team. The ideal candidate will have strong analytical skills and the ability to research and recommend technologies to meet customer requirements.Key ResponsibilitiesResearch and recommend technologies, systems, and solutions based on customer...


  • Thrissur, Kerala, India Boby Chemmanur International Group Full time

    Job Title: Senior Technical DeveloperBoby Chemmanur International Group is seeking an experienced Senior Technical Developer to join our team. As a key member of our development team, the successful candidate will be responsible for creating top-quality applications and collaborating with front-end developers.The ideal candidate will have a degree in...


  • Thrissur, Kerala, India Boby Chemmanur International Group Full time

    We are seeking a talented Senior Technical Developer to join our team at Boby Chemmanur International Group. The ideal candidate will have extensive experience in creating top-quality applications, collaborating with front-end developers, and ensuring that junior staff delivers according to standards.Key Responsibilities:Application Development: Design and...


  • Thrissur, Kerala, India RiDiK (a Subsidiary of CLPS. Nasdaq: CLPS) Full time

    We are seeking a highly skilled Senior Technology Specialist to contribute to a GCP Big Query project. The ideal candidate will have expertise in GCP Big Query and be able to assess the impact of technology on existing systems.Key Responsibilities:Contribute to a GCP Big Query projectAssess the impact of technology on existing systemsDesign and implement...


  • Thrissur, Kerala, India Jwala Diamonds and Jewellers Full time

    **Qualifications and Skills** - More than 6 years of experience in jewelry quality control - Strong knowledge of jewelry production processes and materials - Attention to detail and excellent problem-solving skills - Ability to work independently and in a team - Excellent organizational and time management skills - Good communication and interpersonal...

  • System Admin

    5 months ago


    Thrissur, Kerala, India NEWYEAR GROUP OF COMPANIES Full time

    The System Administrator is responsible for managing and maintaining an organization's computer systems, networks, and servers. This role involves ensuring the stability and efficiency of IT infrastructure, resolving technical issues, implementing security measures, and supporting end-users. The System Administrator plays a critical role in maintaining a...

  • Data Science Manager

    4 weeks ago


    thrissur, India Newpage Solutions Full time

    About the Company NewPage is a digital health solutions company. We devote ourselves to advancing the quality of life by enhancing the health and optimizing the longevity of people. We do this by, passionately building futuristic technologies for global organizations across the healthcare ecosystem. We partake at every stage from problem definition, strategy...


  • Thrissur, India CBTS Full time

    Job PurposeThis position will report to the Managed Services organization and support customers, applications, systems, and vendors with security operations, administration, and general maintenance.The position supports CBTS and its compliance strategy and objectives by performing multiple technical and functional roles. It provides services to mitigate...

  • System Administrator

    5 months ago


    Thrissur, Kerala, India POWER GREEN Full time

    Install and configure software and hardware - Manage network servers and technology tools - Set up accounts and workstations - Monitor performance and maintain systems according to requirements - Troubleshoot issues and outages - Ensure security through access controls, backups and firewalls - Upgrade systems with new releases and models - Develop expertise...


  • thrissur, India Norstella Full time

    Sr Software Development Engineer in TestCompany DescriptionWhy Norstella? Norstella unites market-leading companies with a shared goal of improving patient access. Each organization (Citeline, Evaluate, MMIT, Panalgo, The Dedham Group) delivers must-have answers for critical strategic and commercial decision-making.Together, we help our clients:Assess the...


  • Thrissur, India Texas Instruments Full time

    Why Multi Phase PowerMPP product line offers high performance, innovative and cost-effective power solutions for a broad range of customer applications in enterprise, communications and automotive which include multiple phase DC/DC controllers, smart power stages. In MPP, our mission is to power the processors that power AI & future servers. Target platforms...


  • Thrissur, Kerala, India InCommon Full time

    About the RoleWe are seeking a seasoned Senior Product Manager to join our team at Incommon, a leading provider of Document AI software. As a key member of our product leadership team, you will be responsible for developing and executing the product strategy and roadmap for our Document AI platform.As a Senior Product Manager, you will work closely with our...


  • Thrissur, Kerala, India Hyatt Corporation Full time

    About the RoleThe Chef De Partie will be responsible for supervising the assigned station/section of the outlet kitchen, preparing high-quality products, and ensuring courteous service in line with Hyatt International standards.Key ResponsibilitiesAssist with the efficient running of the department in line with Hyatt International's Corporate Strategies and...


  • Thrissur, India BrainWave Professionals Full time

    Role - Responsible for leading Quality for plants in India, Australia and ThailandQualificationB.E (Mechanical/ Automobile) -Full time from a reputed InstitutionResponsibilitiesEnsuring complinace to Quality Management system according to ISO 9001 standards and IATFLead Continuous quality improvement activities in all plantsEnsure Safe launch and support...