Quality partner - Tuxtla Gutiérrez - UCB

    UCB
    UCB Tuxtla Gutiérrez

    hace 1 día

    Descripción


    Make your mark for patientsUCB is seeking to hire an exceptional Quality Partner, Who will directly support Alliance Partnerships in Mexico to ensure the proper oversight, from a global quality perspective of the activities UCB is performing for all global Alliance partners distributing or receiving global products to/from the different UCB entities.

    The goal of this function is to work with the responsible Quality Lead and act as a back-up as needed to:Ensure global quality practices are integrated inMexicoto ensure compliance and safety obligations are met with regard to UCB and local regulations.

    Maintain the Gx P status of the affiliate in accordance with national and international GMP and legal requirements.
    Manage the local Quality Management System.
    Assist in the identification and mitigation of issues and risks, highlight improvement opportunities and facilitate the development of solutions.
    Ensure all In-Market QA deliverables are achieved in a timely manner.
    Act as the backup of Sanitary Responsible for UCB de Mexico S. A. de C. V.

    according to GMP/GDP regulations, local laws and UCB procedures, including being responsible for final market release of commercial products as needed.


    Major Accountabilities:


    Implement and maintain an effective and compliant Quality Management System in line with the In-Market Quality strategy and according to UCB policies, corporate quality standards, global SOP's, c Gx P and applicable local regulatory requirements.

    Maintain the Site Master File and/or Quality Manual, as required.

    Ensure efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization, from the Territory to the Global QA organization and vice-versa including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN).Represent the area in In-Market Quality meetings, In-Market/Global Quality projects and improvement initiatives, as requested.

    Ensuring the execution of the local Quality Management System, e.g.management of complaints, deviations, change controls, and CAPAs according to UCB corporate SOPs and using the relevant UCB electronic systems;the periodic Management Review to assure consistency and compliance with UCB procedures and local regulations, and to ensure escalation to management of (potential) issues;the periodic Product Quality Review in accordance with the MAH responsibility;quality oversight to Local Gx P Vendors in compliance with UCB Quality Standards and ENG guidance (qualification, quality agreements, vendor management, divestment).

    Approving any subcontracted activities impacting GDP or GMP at the affiliate;establishing and adherence to self-inspection and external audit plans;support execution of local recalls and all related correspondence with national competent authorities.

    Actively engage in the Affiliate Risk to Value process, collaborate with key Gx P and business stakeholders to identify and assess risks, and support the local risk champion in risk mitigation activitiesEnsure compliance to GDP and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable.

    Ensure readiness for all c Gx P internal, external and regulatory inspections.

    Interested? For this role we're looking for the following education, experience and skillsBachelor degree:
    in Pharmaceutical Chemistry and Biology, Industrial Pharmaceutical Chemistry, Pharmacy, or any other field related to pharmaceutical sciences

    English:
    Fluent (H-Reading Comprehension, H-conversation and H-written)3 to 5 years working in similar positions.
    Has knowledge of relevant local legal requirements of the pharmaceutical industry, including the interpretation and practical application of regulations.
    Has knowledge of international GMP/GDP requirements.
    Has ability to work with several projects simultaneously, good organizational skills.

    Be able to identify any issue/inconsistency or missing data and determine when such issue/question need to be escalated to management.

    Self-driven, results-oriented with a positive outlook and a clear focus on high quality.

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