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On behalf of our customer – a Pharmaceutical Company we are looking for an interim Quality Manager & Responsible Person.
Period: 9 months, starting April 1st.
Location: Skåne
THE ROLE
RESPONSIBILITIES
Role overview
Responsible for ensuring compliance across the Nordic countries to EU Good Distribution Practices and Quality Assurance requirements. Acting as the key interface between the regional Quality functions and the local business, ensuring appropriate communication with the Country Manager and other departments such as Pharmacovigilance, Commercial, legal and Medical Information.
The RP position falls within the Distribution QA function of the QA Europe group, whose primary accountability is to ensure that all products on European (EEA) market have been released, stored and distributed in compliance with EU Guideline 2013/C343/01.
Specifically, the position is responsible for:
-Monitoring the contract warehousing and transportation for the 5 Nordics markets (Sweden, Denmark, Norway, Finland and Iceland) and ensure that the quality, safety and efficacy of products is safeguarded during storage and distribution.
-Controlling quarantine, recalls, on hold, falsified medicines and returns from the Nordic markets to ensure that they do not enter distribution.
-Acting as the customer-facing interface for complaints, complaint samples and complaint close-out letters.
-Delivering of Good Distribution Practice (GDP) training internally and to contractors.
-Performing audits on the distribution chain in Europe on behalf of GPNAB.
-Ensuring that Company Nordic`s business in narcotics and controlled / psychotropic pharmaceuticals operates in accordance with SE legislation.
-Support the GPNAB team during local inspections.
-Ensuring the performance of self-inspections and management reviews on a periodic basis.
-Ensuring that a QMS is implemented and maintained in compliance to EU Guideline 2013/C343/01, local legislation and the Company EU QMS.
-Support in the preparation and monitoring of Distribution Technical Agreements.
-Keeping appropriate records of any delegated duties.
Specifically, the post has the authority to:
-Take decisions about handling of products and stop distribution if needed.
-Contact Person for Medical Products Agency (MPA) and reporting to MPA about serious deviations, complaints, recalls, changes, possible falsified products etc.
-Approving/disapproving QA documents from the Quality Management System, Risk Management processes, Change Control processes, Deviation reports, validations concerning GDP processes.
-Implement changes according to GDP/GMP, legislation and guidelines.
-Support European projects to ensure adequate and timely implementation.
COMPETENCE REQUIREMENT AND ABILITIES
Educational Qualifications:
-Life Science degree (Pharmacy, Biology, Chemistry)
Experience:
-Minimum 5 years’ experience in a pharmaceutical distribution quality environment with knowledge of GDP and warehousing / customer service experience.
-Previous experience in a similar Quality and/or PV / device vigilance role within a pharma or medical devices environment.
-Previous experience of pharmaceutical or medical device distribution quality environment with knowledge of GDP and warehousing / customer service experience.
-Basic knowledge of pharmaceutical wholesale or manufacturing quality environment with knowledge of GMP and production experience (desirable).
-GDP Auditing experience (not essential).
Knowledge and Skills (Functional / Technical):
-Attention to details.
-Analytical thinking and problems solving.
-Ability to prioritise effectively and to multi-task.
-Fluent in English and Swedish.
-Basic knowledge of Finnish (desirable), Danish or Norwegian.
-Broad understanding of regulatory requirements and specifics in the Nordic markets with emphasis on the Swedish market.
-Strong project management skills.
-Knowledge, judgment, and confidence to make decisions when faced with ambiguity.
-Must be able to operate calmly and effectively under pressure.
-Resilient, pragmatic, and hardworking.
-Structured thinker.
For more information, please contact;
Anders Larsson, +46 73 203 46 91, anders.larsson@brice.se
Adina Lekberg Salamon, +46 73 974 43 34, adina.lekbergsalamon@brice.se