QA Officer, Quality Assurance department

For Us, It’s A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

Overall Job Purpose:

To perform the activities relating to aspects of product quality to ensure compliance with registered particulars, GDP and GMP.

Main Accountabilities:

• Act as a delegate for the Responsible Person for Wholesale Dealers license
• To ensure compliance with current GDP and GMP guidelines and applicable national regulations
• To manage and develop quality and regulatory compliance systems in line with EU requirements.
• Responsible for the appropriate management of product quality complaints handling in compliance with legal requirements as well as with Mylan Global Policies.
• Review, investigation reports, compile Quality Investigation Reports (QIRs) and Quality Defect Reports (QDRs) to ensure that product investigations and complaints are closed out in a satisfactory and timely manner.
• Write and implement SOPs for local operations in line with Mylan Global Policies.
• Assist in approval of subcontracted activities at the affiliate, which may impact on GDP/GMP.
• Coordinate GDP training for the affiliate staff.
• Manage the self-inspection program and participate in internal and external inspections.
• Effectively manage corrective and preventative action plans and that they are effectively implemented, monitored and closed out.
• Maintain change control process in place to manage all planned major changes with GDP or GMP impact.
• Liaise with NOMA Regulatory Agency on all aspects of pharmaceutical product quality.
• To act as back-up when required within the Nordic quality team for the Mylan commercial affiliates
• Ensure that marketing materials are compliant with at all time Mylan internal regulations and the national regulations.
• Other activities related to Quality, Compliance, GDP might be added when applicable.

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

The QA Officer must be able to cooperate successfully across all functions of the organization, and to represent the company externally in the best possible way. Further, qualified candidates possess the below qualifications:

The QA Officer should preferably meet the following professional skills:

• Formal education at MSc level (pharmacy or other relevant subjects within Life Sciences)
• Have a strong understanding of the Quality processes – a minimum of 3-5 years of QA experience expected
• Experience with ISO, GDP, and GMP regulations; experience from the pharma industry, retail and/or wholesale industry
• Experience with working with medical devices, food supplements and cosmetics is an advantage,
• Must be customer (internal/external) focused and able to deal with ambiguity
• Able to develop a culture of continuous improvement across the department
• Ability to establish a good collaboration with internal and external stakeholders
• Language skills: Norwegian and English at negotiation level

Personal profile:

• Strong interpersonal skills – robust with natural authority, easy going
• Works well in teams and alone
• Service minded; a ‘doer’ – getting things done, also when the pressure is high
• Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity
• Analytical and systematic

Why Mylan and QA:

• An exciting and challenging position where the candidate will secure deliverables on time in high quality.
• The QA Officer will help build, develop and drive the quality and compliance area.
• Mylan is growing, developing speedily – room for making business and success
• Opportunities to develop professionally as well as personally.
• An international and highly dynamic environment, including collaboration with international colleagues and external partners

Interested or any questions?

Please contact Head of Quality Assurance / RP Norway, Achmad Izuddin Nasir  by phone +47 93 89 19 63 or mail yudi.nasir@mylan.com

Deadline to apply for the position is April 24, but applicants will be evaluated consecutively