Regulatory Compliance Expert

4 days ago

Malmo, Skåne, Sweden Sever Pharma Solutions Full time
About Sever Pharma Solutions

Our company develops and manufactures pharmaceuticals and combination products according to applicable regulations and industry standards.

We bring pharmaceutical ideas to life by offering expertise in high potent drug development, enhancing performance, striving for perfection, and providing unique capabilities and expertise throughout the entire process.

For more information about our company, please visit our website www.severpharmasolutions.com.

About QA

The QA department is responsible for ensuring the quality of all aspects within production. Our team offers plenty of opportunities to develop in various areas, making it the perfect place for individuals who want to grow their careers.

We believe that true capabilities result from deep knowledge, experience, and having the right personnel in place. We're building a culture where amazing people can do their best work. If you're passionate about quality assurance and making a difference, you've come to the right place.

About the Position

We're seeking a Quality Assurance Manager for the QA department. As a key member of our team, you'll be responsible for setting the tone for how we interact with our customers internally and externally.

  • You'll oversee the quality status of your product as a QA product owner.
  • You'll serve as the primary QA customer contact person for commercial products.
  • You'll review batch documentation and release bulk and intermediates.
  • You'll handle deviations, OOS, change controls, and complaints.
  • You'll write, review, and approve quality documentation.
  • You'll provide GMP support to other departments.
Key Responsibilities

Your key responsibilities will include:

  • Providing quality assurance and control throughout the entire production process.
  • Developing and implementing quality management systems.
  • Ensuring compliance with regulatory requirements and industry standards.
  • Collaborating with cross-functional teams to ensure seamless production processes.
  • Identifying and addressing quality-related issues.
  • Providing training and guidance to colleagues on quality-related topics.
Requirements

We're looking for an individual with:

  • An absolute passion for quality.
  • A desire to work in a fast-paced and collaborative environment.
  • Ability to work as part of a team and independently.
  • An appetite for driving change.
  • Supportiveness and respect towards coworkers.
  • Resourcefulness and attention to detail.
  • Comfort offering solutions and clarity in ambiguous situations.
  • A relevant academic degree, ideally in Pharmacy, Natural Sciences, or Engineering (equivalent educational backgrounds will be considered for candidates with relevant QA experience).
  • Excellent communication skills in both verbal and written English and Swedish.
Our Values

At Sever Pharma Solutions, we hold our values dear: Making a Difference, Best Workplace, and Close to the Customer.

  • Making a Difference: With the world in focus, scientific, and quality-driven.
  • Best Workplace: Personal Development, Respect and Honesty, Responsibility and Consideration.
  • Closing the gap between us and our customers through long-term relationships, creating value, and flexibility.

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