Quality Specialist (Temporary for 6 months contract)

Are you a promising talent with a passion to work in a global pharmaceutical company and shape your future career as Quality Specialist (QS) in a multi-national company?

If your answer is “Yes”, then we are excited to welcome you to the job opportunity which offers a real career experience commencing from day one.

The position tenure requires minimum 4 days attendance in a week and minimum 6 months of commitment.  

If you’re eager to learn new things,  boost your curiosity, take new responsibilities, and make differences with your ideas and projects which will build your future and personal development, then let’s apply for the job and join us in caring for every heart beat in Daiichi Sankyo!

What does a Quality Specialist?

A QS professional is to involved in Good Clinical Practice (GCP), Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP) (all GxP related activities). As a QS, you will be involved in batch review and management of supply chain – CMO related Quality related issues, change control and validation related activities as well documentation and follow up of Quality related issues such as retention strategies for SOPs, GxP related training actions, control/mentoring of departments from Quality perspectşve, interactions with global Quality Assurance teams and  documentation and validation of all quality – regulatory interfering processes.

All information and actions are documented in appropriate quality systems. Usually, there is a close collaboration between QA GMP and supply chain in order to assure the quality and distribution of the medicinal products and quality systems.

Responsibilities:

• Review of paper and electronic batch records on completeness, clarity and GMP compliance,
• Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPA’s),
• Provide advice to requesting departments regarding GMP aspects,
• Review and approve QS controlled documentation (SOP’s, batch records, working instructions, department processes, CMO related Quality issues, archiving),
• Assessing change requests on consistency, relevance, GMP compliance and clarity (per Regulatory – Quality interference),
• Review/Support of batch release process with management of Quality Manager,
• Support in continuous improvement activities,
• Close collaboration with global Quality Assurance Team for local implementations & quality issues,
• Ensure completion of GxP related training to corresponding roles

Qualifications:

You’re the perfect match if you are;

• Able to work minimum 4 days in a week
• BSc or MSc in biopharmaceutical or biomedical science, chemistry, pharmacy or equivalent,
• Preferably some years of work experience in the pharmaceutical industry,
• Preferably up to date knowledge of current GMP regulations, Quality Assurance processes and Quality related roles (min. 6 months to max. 2 years)
• Good communication skills in English,
• Critical and highly accurate,
• Able to work independently as well as working well within a team,
• Accountable, proactive, continuous learner, curious, collaborative and result oriented

What We Offer:

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

About Us:

We are Daiichi Sankyo, a global pharmaceutical company with over 120 years of scientific expertise!

We are dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, we are primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 120 years of scientific expertise and a presence in more than 20 countries, our company and our 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”