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.
