Senior Quality Assurance Specialist - Uppsala

We are looking for a Senior QA Specialist reporting to Head of Quality & QP

Key responsibilities

  • Support in the company’s important development work related to the Company's technology platform
  • Validate various stages in product development and production processes. This may include methods for API:s, raw materials, intermediates as well as in-process testing methods. Support as QA Tech transfer as necessary of QC and manufacturing processes.
  • Write technical documents such as validation / qualification plans and reports, standard operating procedures, master batch records etc.
  • Collaborate with Contract Manufacturers and licensing partner and work to monitor and improve processes
  • Manage change control, deviation/investigation work in relations to above responsibilities
  • Maintain and meet the highest standards in quality and technical work
  • Work in a team of QA and QC specialists, reporting to the head of Q&QP

Qualifications

  • Several years of experience in Quality Management.
  • Experience with cGxP manufacturing, packaging including electronic QMS systems
  • Experience with GCP is a plus.
  • Experience and knowledge of aseptic working/ aseptic technique.
  • Validation and qualification of equipment, manufacturing facilities, processes and methods
  • Able to perform in-house GxP training
  • Appreciates both the possibilities and challenges of a small and growing dynamic entrepreneurial company
  • Ability to work both independently or as part of a multidisciplinary team sometimes with direct customer or supplier contacts, be self-motivated and have a positive attitude.
  • Ph.D. or M. Sc. in Chemistry, biology, Pharmaceutical Sciences or closely allied life sciences discipline
  • Fluent in written and spoken Swedish and English within GxP

Personal Characteristics

In terms of personal characteristics, the typical candidate is a dynamic and ambitious individual. Open minded, frank, non-political, results oriented; has strong views and can present them with a sound rationale. S/he must be a very results-oriented character. The successful candidate is creative, innovative and entrepreneurial, yet with a strong capability for building structures and processes as well as delivery-on-time mindset.

Position and location

The position is a permanent full-time employment, although a probation period is applicable.

The position will be based in Uppsala, Sweden.

Jan Friberg

Stockholm
Telefonnummer: +46 705 87 12 28
E-mail: JFR@bondi.se
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