Regional GDP Quality Lead

Conteúdo do emprego

Experis IT Switzerland is in a search of a GDP Quality Leadto join one of their clients, a well renowned firm. Due to business expansion, they are seeking a talented candidate to join their existing team. For this temporary project based in Zurich, we are in search of an English speaking candidate who is available to start in November 2022Location: ZurichStart Date: ASAP in November 2022Duration: 6 months with further option of contract extensionWorkload: 100% (2 days home office)Your Tasks

• Drive and ensure timely resolution of product quality & compliance issues in the assigned RDCs, in compliance to Takeda QMS and local regulatory requirements including complaints/recalls, investigations and audit related
• Responsible for notification and escalation of severe GDP events to Takeda management
• Drives risks identification and mitigation for processes linked to and established at the RDCs.
• Ensure compliance to change management requirements at the RDCs and adequate translation into the Takeda QMS.
• Ensure compliance to Falsified Medicines Directive of the RDC(s)
• Perform and/or support GDP Audits at RDCs.
• Represents Takeda during regulatory agency inspections at RDCs.
• Provides support for inspections at Takeda manufacturing sites related to questions for RDC
• Evaluate the level of GMP/GDP compliance and risks for products managed by RDCs in the region through key performance indicators/quality performance indicators and drives the implementation of improvement activities.
• Participate in supporting recall activities, as needed
• Maintain strong collaboration with Supply Chain, Site Quality Organization, RDC related LOC Quality and Takeda project teams.
• Establish or support the establishment of Quality Agreements related to RDC’s
• Process and/or administrate Quality Assurance information in Takeda electronical systems eg SAP, JDE, EQMS, LEADs and other electronic systems.

You Bring

• Scientific Degree (BSc, MSc)
• Strong knowledge of regulations pertaining to GDP, distribution, warehousing and transportation in the region (eg familiar with cGMP/GDP, ISO and ICH requirements)
• Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (re-turns, recalls, complaints).
• Minimum 7 years experience in in the pharmaceutical industry including Quality Assurance, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (eg familiar with cGMP/GDP, ISO and ICH requirements)
• Strong attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/records etc.)
• Prior experience managing external GMP/GDP suppliers
• Skilled at leading GMP/GDP audits
• Fluent in written and spoken English

Don’t hesitate and send us your CV and testimonials today through the link in the advert.