Quality Lead AstraZeneca Sweden Biologics
AstraZeneca Södertälje / Kemistjobb / Södertälje
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hela Sverige Main Duties and Responsibilities
• Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
• Sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
• Development of and continuing suitability and effectiveness of the quality management system.
• Product quality and GMP/GDP compliance through leading quality management reviews. Accountable for initiation, development, implementation and maintenance of Compliance improvement plans and accountable for the timely deliverables of Quality project outputs. Issues and risks are timely flagged and escalated.
• Organisation complies with the relevant cGMPs (e.g. EU, FDA, Japan), health and safety, timekeeping, budgeting, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rule book, the Code of Conduct, quality manual and any other company policies and standards concerning the manufacturing and control of the drug product and participates fully in the audit program, performed by the Regulatory Products and ensures that corrective action plans are agreed, implemented, monitored and completed in order to maintain compliance.
• Provide leadership, direction and mentoring to ensure that the Quality departments successfully meet site objectives in support of Corporate Goals and operates within the regulatory environment.
• Responsible for the quality oversight program which includes real time overview of manufacturing activities inside and outside of aseptic areas, QC and project related activities. The program must result in full adherence to procedures.
Essential Requirements
• Master degree in Pharmacy, Biochemistry or Chemistry.
• Certified as European Qualified Person (EU directive 7513191EEG) and member of SOB or RSC or RPS.
• Language level: Fluent in both Swedish and English.
Desirable Requirements
• Competent People Manager with several years' experience of leading teams.
• Significant management experience in (bio) pharmaceutical industry and several years' experience acting as a QP. It would be desirable for the job holder to have held a similar position (or have similar supervisory experience) supplemented with experience from quality systems, manufacturing, technical support for Research & Development.
• The individual possesses a background in sterile manufacturing, preferably a pharmacist with microbiology, statistics and biochemistry experience.
• Significant experience with Health Inspections (FDA, EMEA).
• Well-developed management styles and proven leadership skills as well as interpersonal skills to facilitate the growth and development of quality staff.
• Possess excellent communication skills, ability to interact at multiple levels within the organisation.
At AstraZeneca every one of our employees makes a difference to patient lives everyday.
We are looking to hire a Quality Lead Sweden Biologics, placement for this role is at our new facility in Gärtuna. As Quality Lead you are responsible for oversight of all Quality Assurance and Quality Control functions at the Sweden Biologics facility, you are the site lead for the Quality Unit, and will direct the development and implementation of quality systems consistent with regulatory requirements and corporate quality policies and will ensure the timely release of commercial and clinical products that meet quality standards.
As the European Qualified Person, the job holder is the primary contact for the Swedish authorities
As part of the collaboration with Site Leadership Team., this individual will play a key contributing role in defining and implementing the values, cultures, goals and strategies of the site.
We are looking for you that have management experience in the bio pharmaceutical area with a broad expertise in Quality Assurance, Quality Control and Health Inspections.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Publiceringsdatum2016-12-23Så ansöker duSista dag att ansöka är 2017-01-02
Ange följande referens när du ansöker: R-002301
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3232174
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