Copenhagen

QA Specialist / QP or Delegated QP

Copenhagen based with travel 20-30 days /year

Salary: Competitive + Benefits + Bonus

If you are a Quality Assurance professional with knowledge and a deep understanding of European Pharmaceutical, EU and ICH quality guidelines than we want to hear from 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 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

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 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative 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:

Your main role and responsibilities will be to assure that Pharmanovia is in compliance with the current GMP and GDP legislation.

  • Maintaining our GMP/GDP/GVP quality systems
  • Writing and maintaining SOP
  • Internal GMP/GDP training of our employees.
  • Reviewing incoming customer issues and preparing responses to internal/external customers
  • Handling risk assessments, change controls, deviations and CAPA.
  • Trend analyses
  • Batch release
  • Quality management reporting
  • Reviewing quality and technical agreements

Perform GMP and GDP audit, and GVP audit at distributers

About you:

  • M.Sc. degree in Pharmacy or another relevant M.Sc. within science.
  • An experience QP or delegated QP
  • Experience gained working with GMP
  • Aseptic production experience would be advantageous
  • Experience with project coordination and analytical skills
  • Excellent IT skills including Microsoft Office
  • Excellent Danish and English communication skills (written and oral).
  • Well-structured/-organized, detail oriented and capable of working independently
  • Able to manage multiple priorities and meet scheduled milestones
  • A team player and be able to work in an international team on complex issues, coordinating efforts with externals partners.
  • Knowledge of Pharmacovigilance

Experience in handling PV information/contract/ADR to PV-consultant

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.

Apply now and become part of our team

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