Qualified Person DelegateApply Now Email Me Job ID SR0020657 Date posted 01/08/2019 Location:Lessines, Belgium
Act as the Qualified Person Delegate for Takeda Manufacturing Site in Lessines, in accordance with applicable regulations.
Perform on time the batch release certification of raw materials, intermediates and final products, in compliance with EU guidelines and MOH requirements
Act as QP delegate for IMP / clinical studies according to EU Annex 13 guidelines
Support the QP in the revision and approval of release, product specifications, documentation,… through the appropriate system, per Annex 16, review of change controls and evaluate if communication to AFMPS is needed
Participate to the Takeda Global QP meetings
Participate actively to audits with authorities from various countries
Support the implementation of site projects for e.g. launches of new products and/or geographies, QC changes methods/ tests in alignment with MOH requirements/ certification,…
Lead and participate projects linked to release activities (raw materials & finished products)
Redact declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes, clarification etc...)
Perform gembas & take part in the improvement of internal processes
Support release team in reviewing and releasing products
At least 3 year experience in a similar environment
Registered Qualified person in Belgium : certified by AFMPS (Belgian royal decree of Dec 2006 art 48)
Knowledge of quality systems, EU and FDA regulations, cGMP, GDP, Eudralex, Annex 16, Annex 13
Fluent in French and English (spoken and written knowledge)
Ability to work in a multi-disciplinary team environment
Fact-based / Critical thinking / Rigor / proactivity / Stress-resistant
Good organizational, planning and communication skills
Learning attitude and continuous improvement mindset
Computer skills: MS Office (advanced knowledge in Excel is a plus)
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
In Lessines, Takeda is producing drugs for immunological and hematological therapies. The main activity of the site is the purification of plasma immunoglobulins for the treatment of primary immunodeficiency, as well as the treatment and conditioning of coagulation factors for haemorrhagic disorders (haemophilia A and B). As a production site, the Lessines factory operates 24/7 and employs more than 1000 people.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.