Quality Assurance Associate

Quality Assurance Associate

Copenhagen, Denmark (Hybrid role, with up to 2 days work from home possibility)

Salary: Competitive + Benefits + Bonus

Are you a detail-driven and pragmatic pharmaceutical QA professional, with a passion for compliance and quality?

If you thrive in a fast-paced environment and want to grow your career in a global business that's making a real difference in healthcare - this is the opportunity for you!

Join us to help improve peoples' lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As QA Associate you will be responsible for all activities related to finish goods manufacturing activities, daily operations, optimization projects, and partner collaboration both for Pharmanovia A/S and Atnahs ApS.

You will be responsible for ensuring high standards of quality and compliance within the pharmaceutical operations, coordinating cross-functional projects, and supporting both local and international teams. You will bring a pragmatic, proactive, and structured approach, and be able to manage multiple priorities in a fast-paced, versatile and diverse role in a multi-cultural environment.

The position is based in Copenhagen, Denmark.

Main responsibilities & duties:

Quality Management System (QMS) Governance

• Maintain the QMS according to applicable legislation (GMP and GDP)
• Documentation and archiving, hereunder SMF and QM
• Regulatory monitoring
• Training and training oversight incl. documentation

Quality Operations

• Batch Review, preparation of CoC + CoA
• Deviation, CAPA and Change Control handling
• Supplier and customer handling
• Global QA assistance (external and QMS)
• Optimization projects involvement in Global QMS

Distribution & Product Handling (GDP Operations)

• Handle and coordinate return cases together with 3PL and Site RP, ensuring RP decisions on saleable vs. destruction
• Handle and coordinate controlled drugs with Supply Chain including reconciliation

Audits & Quality Governance Forums

• Participation in internal audits and self-inspection as auditee and co-host
• Arrange and lead QA meetings and reviews including QA board meetings facilitation

Development plan

• Deputy Responsible Person (in scope)

About you:

Candidates with progressive experience in the pharmaceutical industry, with a strong understanding of GMP and GDP processes, ideally with audit experience and within a virtual company setting, are likely to have the skills required to be successful in this role. We are also looking for:

• Master's degree in pharmacy, Science, or a related field
• Strong understanding of GMP and GDP processes
• Prior audit experience (hosting/auditee) is desirable
• Experience with Trackwise and SAP is preferred
• Excellent Danish and English communication skills (written and oral)
• Strong coordination and analytical skills
• Exposure to multi-cultural workplaces and experience in cross-functional collaboration
• Pragmatic and proactive approach with a positive and flexible mindset
• Creative thinking and willingness to learn and adapt
• Ability to multitask effectively ("Octopus" skills)
• Experience working in a small office team within a larger multinational organization, ideally in a virtual company setting
• Well-structured, organized, detail-oriented
• Team player with the ability to work independently and within an international team

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.