Qualified Person, QP Pfizer Strängnäs i Strängnäs

Strängnäs, Södermanlands län
Läkemedel, bioteknik & medicinteknik
Full time
Sista ansökningsdag:
Ellinor Crafoord
Do you want to work with frontline biopharmaceuticals that makes a difference in quality for life? Do you want to work at a manufacturing site where every employer counts and each individuals engagement makes a difference? Do you have qualification to be Qualified Person? Then the position as QP at Pfizer Strängnäs is for you!

Pfizer Strängnäs is a modern world class manufacturing site situated in the picturesque surroundings of Strängnäs. The site has a Quality Operation (QO) department that consists of approximately 65 colleagues. As QP in the Quality Operation in Pfizer Strängnäs, you will be responsible for assuring that the quality of released drug substance and intermediate batches fulfill legislation and requirements of current GMP.

In your role you will play a key function, for both the QO and the whole manufacturing at site, in giving direction and guidance to processes for effective Quality Assurance for drug substance release. You will work with developing Quality Systems and quality culture and will be given the opportunity to both influence QO and the entire site together with a network of international colleagues.

Your area of responsibility will involve:

• Release of drug substance and intermediate batches

• Review and approval of significant deviation investigations

• Approval of QP Declarations and other documents

• Develop our Quality Systems in collaboration with current responsible persons

• Participate in internal and external inspections

• Lead quality related improvement projects

• Participate in cross site product and tech teams

• Site contact person for authorities, other sites within company and other companies

• Perform training in the area of responsibility

• Subject Matter Expert for quality related and GMP questions

How to apply: Apply at www.dfind.se/science-engineering. We would like to have your application in English, no later than 2018-05-08

For information: In this recruitment Pfizer is collaborating with Dfind Science & Engineering. For information contact Senior Recruitment consultant Ellinor Crafoord, +4673-3434502

Position: Fulltime, open-end

Location: Strängnäs, Sweden

Do you want to contribute the better health with release of frontline drug substance?

- Don’t wait!

• A Master degree in a Science or Pharmaceutical related discipline

• Solid knowledge of global GMP and regulatory requirements

• At least 10 years’ experience in pharmaceutical manufacturing and major parts of that in Quality

• Meet requirements for Qualified Person in accordance with LVFS 2004:7

• Experience of working in a global environment

• Fluent in written and spoken Swedish and English

Experience in working with manufacturing processes for Biologics is a strong merit

As a person you are structured, organized, self-directive and have ability to clearly communicate your decisions to all levels on site. You are expected to be a role model for others and willing to take on a wide variety of tasks and responsibilities.

Company description:
Pfizer Strängnäs is Sweden’s largest Biotech facility for commercial manufacturing of pharmaceutical drug substances with approximately 230 employees. They manufacture several drug substances and protein intermediate in a multi-product and a dedicated facility. The Quality Operation is organized in one QA team, one QA Compliance team and a QC team. The function consists of approximately 65 colleagues. You will work closely with both QA, QC and QA Compliance colleagues and be part of the QO leadership team. You will report directly to the QO Director. Pfizer is a company that focuses on innovation, creativity and respect for patients, colleagues and society. We have an effective manufacturing organization with focus on continuous improvements, Six Sigma and Lean.