QA Document Control Specialist to Aprea Therapeutics in Solna

Job description
Do you have a scientific degree and QA knowledge from the Pharma or Biotech industry? Are you a structured and organized person with an attention for detail? Do you have experience from working in a quality management system? If you looking for an opportunity to put your knowledge in use and want to do so in an exciting and inspiring environment within novel cancer therapeutics then this might be the role for you! We are now, on behalf of our client Aprea Therapeutics, recruiting a QA Document Control Specialist to manage Apreas quality documentation and training systems! The role will be placed in Solna and the starting date is to be agreed with the right candidate. 
The role.

Responsibilities
 As QA Document Control Specialist you will be responsible for implementation and maintenance of Apreas controlled document management system. You will manage documents from QA, CMC and other key departments to ensure that the GXP regulated documents are filed systematically. Your tasks will also include troubleshooting the quality documentation and maintaining the training systems.

Your main duties include:
• Identify opportunities for process improvement in the document control and training systems and work cross functionally to implement, as appropriate.
• Review and approve controlled documentation such as policies, SOPs, work instructions, forms, and templates.
• Manage the full life cycle of the controlled documentation within the document system.
• Manage Aprea’s training documentation and processes.
• Participate as a QA/QS representative in internal cross functional driven projects.
• Assist Aprea´s different departments in the implementation, training and maintenance of the controlled document management system. 
• Provide guidance and training to staff regarding the controlled documentation and the document control processes.

Qualifications
Education and experience
• Minimum of bachelor’s degree in a relevant scientific or health field.
• 3 –5 years of relevant work experience in a QA/QS environment working with and/or handling documentation.
• Experience in working within project teams regarding quality or compliance concerns.
• Fluency in English both written and orally is a requirement.
• Experience from working with electronic Document Management Systems (eDMS) is meritorious.
• Swedish is meritorious

Skills and abilities
• Knowledge of quality assurance concepts and practices within the Pharma or Biotech area.
• An understanding of quality systems and regulatory compliance requirements within the Pharma or Biotech area.
• Ability to independently optimize some commonplace compliance procedures.

Application
The last application date will be on 2020-08-31. If you find the role interesting and match the candidate description then do not hesitate to apply since we will be handling applications continuously.

Because of GDPR we are not allowed to handle applications sent by e-mail and these applications will therefore be denied.

In this recruitment process Aprea Therapeutics Inc. is collaborating with Randstad Life Sciences. For further information regarding the position please contact recruitment consultant Heidi Pettersson, heidi.pettersson@randstad.se.



About the company
Aprea Therapeutics Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics to reactivate the mutant suppressor protein p53, the most commonly mutated gene in cancer.