Mylan Healthcare B.V.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Responsible Person role will make an impact:
Key responsibilities for this role include:
- Undertake the role of RP in line with the European and Dutch regulatory requirements for pharmaceutical wholesalers (see appendix for clarifications of tasks)
- Create and manage a Quality Management System for BGP PO GmbH in The Netherlands
- Apply for and maintain WDA/GDP authorisation of BGP PO GmbH in The Netherlands by ensuring the EU, Dutch guidelines and internal policies / SOPs are met and, being the primary representative of such authorisation with the Dutch health authority and during GxP inspections
- Administrative / quality checks of BGP PO GmbH products for particular EU markets
- Ensure that Quality related issues are dealt with in a GxP manner and efficiently to ensure continuity of supply
- Supplier and Customer management: supplier and customer qualification / bona fide checks, generation and/or review of Quality Technical Agreements
- Management of pre and post market supply incidents, complaints, returned goods, CAPA Management, Change Control and product recall, along with communication to the Dutch health authority as appropriate
- Write or review procedures (SOPs/WIs) concerning GDP, perform and plan self-inspections
- Stay abreast of local and regional regulatory requirements ensuring Quality Management Systems are always compliant and ‘inspection ready’.
- Maintain communication with Regional and Global Senior Leadership and, act as a Quality Lead representativeMeet objectives as agreed and carry out any other duties as directed by the Regional and Global Senior LeadershipReporting to HA on imported/exported amounts of controlled drugs, (Yearly) check on licenses of customers
The minimum qualifications for this role are:
- BSc and/or higher University level pharmaceutical qualification or life-science graduate
- Minimum of 5+ years as an established RP within the Netherlands
- Experience with establishing and operating a Quality Management System within the pharmaceutical industry
- Proven competency and experience with communicating with the Dutch health authority / hosting Dutch health authority inspections
- Experience with various IT systems such as; warehouse management systems (preferably SAP), Document Management systems (such as Documentum), electronic Quality Management Systems (Trackwise or equivalent)
- Is highly autonomous, has the ability to predominantly work independently with minimal supervision, but who also has the ability to work and collaborate within dynamic cross-functional teams
- Highly motivated individual who has the desire to succeed and can work under pressure, who is willing to walk the extra mile and is able to deliver the objectives within tight time frames and budgetary constraints
- Has ability to have a lot of initiative and can make well-considered decisions
- Is customer focused, takes responsibility and, has a hands-on mentality
- Able to prioritize and keep an overview with complex situations/process and points out possible bottlenecks and consequences, is creative in finding solutions and achieving win-win situations
- Working proficiency in Dutch and English language
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!
We reward and acknowledge your contributions and offer the following:
- Great Place to Work certification, demonstrating that we offer a great employee experience and being an employer of choice
- Competitive compensation package inclusive of annual discretionary bonus
- Focus on career progression with growth and development opportunities
- Hybrid work model and home working budget
- Emphasis on Health and Wellness programs
- 35 vacation days
- Contribution free pension plan
- Contribution free disability insurance and contribution free accident insurance
- Contribution free life insurance
- Healthcare insurance allowance
- Internet allowance
- Paid additional birth leave for partner
- Leisure discount program
- Fun social events, great barista coffee and a friendly and supportive environment
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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