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Qualified Person


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Job Details

We are now looking for an experienced Qualified Person (QP). As QP, you will be responsible for assuring that the quality of released drug substance and intermediate batches fulfill legislation and requirements of current GMP. 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 and QA Compliance colleagues and be part of the QO leadership team (reporting directly to the QO Director). 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.

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

Your skills and qualifications will ideally include:

+ 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 parts of that in Quality Assurance

+ 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

The closing deadline for applications is 7th February 2018.

For more information about the position please contact: Eva Trnkvist, Director Quality Operations, +46 152 27648

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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