Vacant job

Birka BioStorage AB is a growing company that offers secure storage and distribution of customers' research samples, reference samples, drugs, active substances, etc. according to GMP and GDP. The customers are Swedish and global companies working with substance/drug manufacturing, pharmaceutical research, and development. The business is located in Lund and is now preparing to launch new capacity and new services.

We are looking for someone who wants to join our exciting journey and strengthen our QA function. Our operations have limited Eur GMP manufacturing authorization focusing on storage and logistics, as well as limited GDP authorization for storage and distribution of investigational drugs and active substances within various temperature ranges. We are planning to launch new services including sampling, analysis, labeling, and repackaging.

Responsibilities include:

• Guide and educate logistics and technical teams on GMP and GDP issues
• Initiate training documentation for new employees
• Establish and adapt controlled documents and instructions (SOPs)
• Review, investigate, and assess monitoring data, deviation and validation documentation, change controls, risk analyses, and other quality documents such as logbooks and maintenance documentation
• Participate in and draft management reviews
• Conduct supplier audits and update the critical supplier list/plan
• Plan and conduct internal audits
• Follow up on improvement measures within GMP and GDP
• Participate in and follow up on customer audits and regulatory inspections
• Draft supplier agreements as well as quality agreements
• Assist management in regulatory matters
• Drive new customer projects from a GMP/GDP perspective
• Participate in the development of new services

Your profile:

To succeed and thrive in the role, you are a positive and solution-oriented person who enjoys constantly facing new challenges and can manage a large network of contacts and broad collaboration across different functions. You need to see the big picture and switch between business development and customer focus. You have the ability to communicate in a trustworthy manner, be the face of the company in quality matters, and prioritize the best interests of the business.

Education:

Pharmacist/pharmaceutical technologist/graduate engineer/master of science in engineering who meets the requirements to become a QP and RP for limited drug manufacturing and distribution.

Desirable:

• Good knowledge of English, both spoken and written.
• Your education meets or has the potential to meet the competence requirements for Expert in LVFS 2004:7.
• Several years of experience in a GMP and/or GDP regulated environment as a Quality Assurance specialist and/or as a QP/RP from a pharmaceutical manufacturing company, API manufacturing company, distribution company, or similar according to GMP/GDP.

We offer a calm and harmonious work environment.

We apply collective agreements.

Birka BioStorage AB does not request assistance from recruitment agencies for this position.