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Quality Partner Mexico

hace 6 horas

Ciudad de México, Ciudad de México UCB A tiempo completo

Make your mark for patients

UCB 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 in Mexico to ensure compliance and safety obligations are met with regard to UCB and local regulations.
  • Maintain the GxP 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, cGxP 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 inIn-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 GxP 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 GxP and business stakeholders to identify and assess risks, and support the local risk champion in risk mitigation activities
  • Ensure compliance to GDP and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable.
  • Ensure readiness for all cGxP internal, external and regulatory inspections.

Interested? For this role we're looking for the following education, experience and skills

  • Bachelor 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.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
About Us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.