Senior Quality Affairs Officer

Mylan B.V.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.
 

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Affairs Officer role will make an impact:

Key responsibilities for this role include:

• Undertake the role of QP and RP in line with the European and Dutch legal requirements for pharmaceutical manufacturers/importers and wholesalers

• Manage (local) Technical Agreements, Supplier qualification

• Management of PMSIs and incidents, CAPAs, Changes, Complaints, Self-inspections, Recalls, PQRs

• Review of GMP/ GDP documentation and advice with respect to regulations

• Ensure procedures (SOPs/WIs) are in line with EU, international legislation and internal policies and procedures.

• Act as (co-)host during internal corporate or external (authorities) audits/inspections

• Act as point of contact for the Competent Authorities on specific issues

The minimum qualifications for this role are:

• Life-science graduate or pharmaceutical qualification, preferably as (industrial) pharmacist

• At least 5 years Pharmaceutical Affairs experience covering all aspects of GMP/GDP.

• Dutch Native language and excellent in English (both in writing and speaking)

• A thorough knowledge and understanding of Dutch Medicines Act and EU – and local GMP/GDP legislation and associated guidance and other applicable regulations

• Highly motivated individual who has the desire to succeed and can work under pressure

• Is able to prioritize and keep an overview with complex situations/process, is creative in finding solutions and achieving win-win situations

• Ability to easily change between the different decision criteria and processes, covered by and belonging to the different key responsibilities in this role

Reporting to the Head of Quality Affairs , the ideal candidate needs to be an enthusiastic, well-rounded and motivated team player with excellent people skills. You will have a collaborative approach to work and the ability to communicate effectively with multiple stakeholders, and able to work autonomously and drive own work outcomes.

At Viatris Netherlands, we offer an inclusive, engaging, and high-performing environment where you can use your experience, perspective and skills to help make an impact - come and join us!