Senior Qualified Person - Quality Center NL
Date : Feb 25, 2021
Location : Haarlem, NL, 2031 ga
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Company : Teva Pharmaceuticals
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day.
We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.
We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
The Quality Qualified Person II-Quality Center NL is a staff position located onsite at our prouduction facility in Haarlem, reporting directly to the Director Commercial Quality NL.
This role supports the release operations from a QP batch release perspective as well as issues involved in the release process, in close collaboration with the Release team of Quality Center NL.
Ensure review of batch documentation and validation documentation is done in such a way that local standards are met and compliance with the Marketing Authorization is assured.
Ensure QP batch certification of commercial medicinal product (bulk and / or finished product), according to EU GMP Annex 16, for NL and EU market.
Ensure QP batch certification for clinical supplies as a service for R&D, according to EU GMP Annex 13, for EU market.
Review and approve change controls, deviations and CAPA in a timely manner and ensure that quality standards and GMP requirements are met.
Review and approve quality complaints in a timely manner and liaise with manufacturing site, packaging site, testing site and / or distribution center to trigger corresponding investigation and adequate corrective and preventive actions.
Liaise with pharmacovigilance department if necessary.
Lead critical quality and / or complex investigations and support local or regional Commercial Quality Units to elaborate and to deploy action plan.
Ensure preparation of appropriate communication with local and or other EU authorities.
In case of recall ensure local coordination between Pharmacovigilance, Medical Affairs, Regulatory Affairs, Supply Chain etc and with the EU Qualified Person concerned and provide the Director Commercial Quality with input for escalation process.
Review and approve where applicable site changes and technical transfers to be in compliance with EU GMP and Teva Standards.
Create, keep up-to-date and distribute Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national and international regulations.
Master s Degree in Pharmacy, Biology, Microbiology, Chemistry or an equivalent combination of education and experience to the functional role.
Minimum 4 years of experience as a Qualified Person in the pharmaceutical industry.
Demonstrated knowledge and working experience of pharmaceutical industry as it relates to Quality Compliance.
Working knowledge of pharmaceutical operations and supply chains.
In-depth understanding of GMP & GDP regulations and the professional duties of a QP as per Article 49 of Directive 2001 / 83 / EC.
Experience with development and implementation of Quality Systems and application of risk assessment tools.
Proficient computer skills in current software including MS Office.
Excellent English proficiency
Director Commercial Quality Quality Center NL & Cluster Head Benelux / Nordics
Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment.
More information on this verification and vetting will be provided if you reach this stage of the application process