Do you want to combine the opportunities that a global company provides with the advantages of a family-owned business? Octapharma is a biotechnology pharmaceutical company with several manufacturing plants across Europe (Sweden, Austria, France, Germany - with a vision to improve people's health and lives.
What will you do as a Corporate QA Manager / Reviews and Projects?
- Review and approve qualification and validation documentation (URS, IQ, OQ, PQ, PPQ, …) for corporate projects (facilities, equipment, utilities and IT systems) in accordance with GMP and Octapharma standards
- Review and approve corporate procedures in relation to Qualification/Validation process, IT and IT applications...
- Responsible for qualification including audits of suppliers and service providers involved in corporate projects
- Provide a compliance in the corporate projects, attend all corporate project meetings as QA expert
- Subject matter expert in QA related tasks and qualification/validation of facilities, equipment, utilities and IT systems.
- The position require travelling, approximately 20%.
- University or College Graduation in e.g. Chemistry, Chemical Engineering or Pharmacy.
- At least 5 years experience of working with quality related tasks within pharmaceutical industry with deep knowledge of current GMP (Eudralex Volume 4 and US Code of Federal Regualtions) including Part 11 and Annex 11 for computerised systems and Annex 15 for qualification/validation
- Documented training in qualification/validation in Pharmaceutical Industry with good knowledge of different quality system standards relevant for qualification/validation of facilities, equipment, utilities and IT systems (e.g. ISO 9001, GAMP, ISPE guidelines).
- Very good English skills, both verbally and in written
- Documented training as lead auditor (internal and/or external).
Corporate Quality Assurance within Corporate Quality
- Overall responsibility for quality assurance of our medicines
- Regulatory compliance and quality assurance for comprehensive systems
- Manufacture of biological medicines entails extra high-quality requirements
- Works together with other functions related to everything from the blood plasma we use as raw material to the final release of the finished product to our patients
- The Corporate Quality Assurance consists of 13 people and you report to the head of the department
What is the best thing about working with us?
- You contribute to saving lives - Every day is meaningful as we manufacture life-saving medicines
- Benefits – Bonus program, benefits portal with advantageous deals and offers as well as naprapat at the workplace and more.
- Family values - Long-term perspective regarding personnel and relationships
- Bistro bryggeriet – Homemade food is served every day and we have our own bakery/café
- Historic and unique work environment – State-of-the-art offices originating from Stora Bryggeriet (a beer brewery from 1892)
- Competence development - We offer, among other things, several different employee and leadership training courses, both internal and external, trainee programs and digital solutions
If you have questions about the position, contact Muriel LeHenaff at email@example.com. The application deadline is 2023-04-28, the position can be filled before then.
Please attach your resume written in english.
If you go further in the process
- We want to collect as much information as possible early in the process to be able to make the best match
- Within a few days, you will be able to carry out occupational psychology tests
- The tests are done early in the process because we want to ensure an objective, unbiased and fair selection process
Unionen, Zahra Kafash-Hoshyar, 08-566 433 13
Akademikerföreningen, Ann-Charlotte Hinz, 08-566 431 35