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    Quality Manager - Lisboa, Portugal - Grabjobs Portugal

    Grabjobs Portugal
    Grabjobs Portugal Lisboa, Portugal

    há 2 dias

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    Descrição

    About Valgenesis:

    We're a rapidly growing global SaaS company that helps life-science organizations bring lifesaving products to market with increased quality and reduced ecological impact.

    Our customers include 30 of the top 50 global pharma and biotech companies. We lead our market through innovation and by delivering value over web, mobile, IOT, AR channels and consulting services.


    Workplace type:
    Hybrid


    Key Responsabilities:

    • Overall responsibility for Quality Management Processes in line with the standard requirements of ISO 9001:2015 and

    ISO:
    27001:2013.


    • Knowledge of Risk-Based Approach to Compliant GxP Computerized Systems - GAMP 5
    • Implementation of the validation strategy for ValGenesis computerized systems and associated infrastructure.
    • Support the product development life cycle for computerized systems with change controls, deviations management ensuring that relevant documentation is in place and maintained according to the ValGenesis requirements.
    • Understanding of computerized systems validation, lifecycle management and 21 CFR Part 11 requirements.
    • Coaching and mentoring of QC team members.
    • Defines, documents and implements QMS for all product development areas including support functions.
    • Planning and implementing promotional campaigns for the specified regions.
    • Responding to and managing Customer Complaints by investigation and implementing countermeasures for corrective and preventive measures.
    • Conduct and manage the internal audits including vendor audits and report to Head of Quality / Management
    • Provide support to department heads and functional heads to identify improvement areas by identifying the root causes and propose the best corrective and preventive actions.
    • Creating innovative solution with problem solving methods to bring in leads.
    • Customer focus with eye for details, analysis and continual improvements.
    • Managing with day to day quality control activities are as per quality plan requirements and track them to closure.
    • Up to date with the latest development of the standards and other regulatory needs in the pharmaceutical industry and maintain compliance to the QMS.
    • To review and approve the various validation documents both internally as well as during product deployment for customers. The documents are routed in a workflow with predefined SLA and the expectation is to review thoroughly without any defects or missing content.
    • Support on Information Security Management System in terms of review of documents and ensure that is line with the requirements of security standards.
    • Improve compliance through continual improvement programs across the organization and Quality by design.
    • Support training department in terms of training plan, conduct of training and management for the ValGenesis.

    Qualifications:
    Graduate with having worked in Software development and quality control areas Product development lifecycle knowledge along with knowledge on testing and validation Knowledge of Information Security and associated functions Excellent communication skills (Both written and oral)

    Customer Management and inter personal Skills Self-starter, well organized and self-motivated Strong analytical and project management skills Confident and dynamic personality Strong creative outlook driven by innovation and problem solving skills Attitude to learn and perform new areas including life sciences domain Preferred:

    Work experience in Quality Control specific to software development for pharmaceutical / life sciences domain Knowledge on statistical and quantitative methods Degree in Business administration /Management with QA specialization Only candidates based in Portugal aligned with the requirements presented will be considered Headquartered in South San Francisco, since 2005 we've grown into a global organization with offices around the world.

    ValGenesis is the global market leader and fastest-growing provider of digital validation software for life science companies. We are proud to partner with 30 of the top 50 global pharmaceutical and biotech companies.

    Our SaaS platform and flagship product, Validation Lifecycle Management System (VLMS), is the first enterprise software solution to fully electronically manage the validation process lifecycle, accelerating time to market, reducing manufacturing costs, and increasing quality and regulatory compliance for our customers.

    As a first mover supporting the pharmaceutical, biotech, and medical device industries, ValGenesis is pioneering innovation over web, mobile, IoT, and AR channels.

    For more, see the Paperless Validation Software Solution ValGenesis video.
    ValGenesis is an equal-opportunity employer.

    All qualified applicants will be considered for employment without regard to race, age, national origin, religion, marital status, sexual orientation, ancestry, color, gender identity/expression, family/medical care leave, genetic information, medical condition, physical/mental disability, political affiliation, status as a protected veteran, status as a person with a disability, or other characteristics protected by laws or regulations.

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