Responsible Person Deputy (RP Deputy) – 100% (temporary role from 01.01.2021 – 31.12.2021)

Gsk (Bern BE, Schweiz) Vor 21 Tagen veröffentlicht
Site Name: Switzerland - Muenchenbuchsee Bern
Posted Date: Oct 20 2020

Are you interested in a RP Deputy position role that allows you to support the Responsible Person and ensure that the mandated GSK Quality Management Systems requirements and applicable legislation requirements are met in GxP-related operations of GlaxoSmithKline AG (GSK) and ViiV Healthcare GmbH (ViiV)? If so, This RP Deputy role could be an ideal opportunity to explore.

As a Responsible Person Deputy your tasks will be the following:

Main Responsibilities:

  • Ensure that medicinal products and medical devices for GSK and ViiV are manufactured, imported, released, stored and distributed in Switzerland according to GMP, GDP and local regulatory requirements.

  • Decide whether or not to release a batch, independently of the company’s executive board.

  • Deputize RP in interaction with local authorities.

  • Support implementation and maintenance of the Quality Management System in the local operating company.

  • Maintain oversight and coordinate GDP and quality-related processes of the external pre-wholesaler.

  • Engage in management review process.

  • Engage in quality risk management.

  • Perform self-inspections and audits of GxP-related operations.

  • Engage in qualification of GMP/GDP suppliers and customers.

  • Engage in review and approval of Quality Agreements.

  • Review and approve repacking activities.

  • Perform technical evaluation of product complaints and engagement with customers, manufacturing sites and Pharmacovigilance.

  • Evaluate Product Quality Reviews (or Periodic Product Reviews)

  • Support inspections pertaining to the license to operate.

  • Perform other legal duties of deputy RP related to the Licenses under Swiss law and applicable regulations.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • University Degree in Science or Pharmacy, higher degree (PhD) beneficial.

  • Minimum of 5 years of experience in a GxP regulated pharmaceutical field.

  • Deep understanding of GxP regulations.

  • Proven track record with Health authorities, especially Swissmedic/RHI.

  • Experience in performing batch record review and batch release to the market.

  • Professional written and verbal communication skills, fluency in German and English languages. Additional national languages would be an advantage.

  • Ability to engage and motivate stakeholders at any level of the LOC organization.

  • Good time management skills, with ability to multi-task and work under pressure.

  • Works with a spirit of continuous improvement and innovation, open to new ideas and methods.

  • Computer literacy in Microsoft Office applications. Knowledge of SAP, Trackwise and Veeva platforms would be an advantage.


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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Responsible Person Deputy (RP Deputy) – 100% (temporary role from 01.01.2021 – 31.12.2021)

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