Quality Assurance Manager

2 weeks ago

Malmo, Skåne, Sweden Sever Pharma Solutions Full time

About Sever Pharma Solutions

At Sever Pharma Solutions (SPS) we develop and manufacture pharmaceuticals and combination products in accordance with applicable regulatory requirements and industry guidance.

We bring pharmaceutical ideas to life by offering expertise in high potent drug development, a drive to enhance performance, a passion for perfection, and a commitment to provide our customers with unique capabilities and expertise throughout the whole journey.

For more information about the company see our website www.severpharmasolutions.com.

About QA

Our department takes care of all aspects of Quality Assurance at the company within projects and production. With us, there are plenty of opportunities to develop in various areas. It's the unique contributions of all our QA team members that drive our success.

We believe that true capabilities result from deep knowledge, experience and having the right personnel in place. We are building a culture where amazing people (like you) can do their best work. If you are ready to grow your career and be part of a team improving the daily lives of patients across the globe, you've come to the right place.

About the Position

We are looking for an experienced Quality Assurance Manager for the QA QC Compliance & Projects department. You'll be part of a team setting the tone of who we are by how we act with our customers both internally and externally.

What you'll be doing day to day:

  1. Being a QA system/project responsible.
  2. QA representative in internal projects and customer projects.
  3. Having an overview of the quality status of your system/projects.
  4. QA customer contact person for projects.
  5. Handling deviations, OOS, Change controls & complaints.
  6. Writing, reviewing and approving quality documentation.
  7. Providing GMP support to other departments.
  8. Participation in regulatory authority inspections/internal or external audits.
  9. Collaborate with cross-functional teams to align QA initiatives with business and operational objectives.
  10. Project support, and time management skills, writing, coordination, and execution of more complex QA items.
  11. Reviewing of batch documentation (when required).
  12. Handling Validation and Qualifications documents.

What are we looking for in our next QA Manager?

  1. An absolute passion for quality.
  2. A desire to work in a fast-paced and collaborative environment.
  3. Ability to work as part of a team and independently.
  4. An appetite for driving change.
  5. A fun can-do attitude.
  6. Being supportive and respectful to coworkers.
  7. Resourcefulness and attention to detail.
  8. Comfort offering solutions and clarity where there is ambiguity.
  9. An academic degree ideally within the field of Pharmacy, Natural Sciences or Engineering. (Equivalent educational backgrounds could be considered for the right candidate who has relevant QA experience).
  10. Although we are based in Malmö and have many documents/meetings in Swedish, we are an international company with international customers, so excellent communication skills both verbally and written in English as well as Swedish is a requirement.

Our Values

SEVER's values are important to us, and it is therefore important that you also share them:

Making a difference

  1. With the world in focus.
  2. Scientific.
  3. Quality.

Best workplace

  1. Personal Development.
  2. Respect and honesty.
  3. Responsibility and consideration.

Close to the customer

  1. Long-term relationships.
  2. Create value.
  3. Flexibility.

Questions and Support

If you are passionate about driving quality and making a difference to people's health, we'd love to meet you Send your CV and cover letter no later than 17th March 2025. We will review applications continuously; therefore, the position can be filled before the last application date, so don't hesitate to apply.

If you have more questions about the position, please contact Maria Erlandsson, QA QC Team Leader Compliance & Projects, Qualified Person.

(maria.erlandsson@severpharmasolutions.com)

A background check will be part of the recruitment process for the final candidate.

Union representatives:

Sofia Lindebring, Unionen phone. +46 (0)40-641 70 87.

Frida Dahlström, Akademikerförbundet phone. +46 (0)721 45 23 23.

We look forward to your application

#J-18808-Ljbffr

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