Validation Manager, AstraZeneca Sweden Biologics
AstraZeneca Södertälje / Maskinförarjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla maskinförarjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos AstraZeneca Södertälje i Södertälje,
Huddinge,
Solna,
Mölndal eller i
hela Sverige The role
The Validation Manager is responsible for the Validation Processes at the Sweden BioManufacturing Center. They are the subject matter expert and represent the site for validation activities. They are a leader in process and validation improvements and initiatives and responsible for the management of validation budget and appropriate resources.
Accountabilities/Responsibilities
• Subject matter expert in validation regulatory guidelines and procedures for sterile biopharmaceutical manufacturing, including representing Validation during regulatory inspections.
• Develop and manage the validation strategy for the Sweden Biologics Facility
• Dealing with complexity (Ambiguity and Conflicting priorities) - exercising good risk based judgement associated with the change management process.
• Work collaboratively with Sweden Operations partners to ensure effective use of knowledge and resources.
• Direct day to day operations of manufacturing, facility, computer, and cleaning validation services
• Program manager for multiple validation projects
• Technical expert for process improvements, investigations and troubleshooting
• Prepare, coordinate execution, review, and approve in-depth process validation protocols and reports (computer, facilities, process, and cleaning)
Minimum experience
• Substantial knowledge of cGMP, in particular Biologics manufacturing and/or laboratory practices, with Aseptic experience.
• Good knowledge of production equipment, facilities, engineering and instrumentation
• Knowledge of engineering terminology and requirements in regards to equipment together with strong technical report writing skills and excellent communication skills
• Provide technical training and underpinning knowledge training to manufacturing department to improve process and analytical knowledge, and understanding of the manufacturing operators
• Knowledge of ICH guidelines and experience in analytical validation
• Effective problem and conflict resolution skills and proven team focus
Preferred experience/requirements
• Familiar and experienced with relevant enterprise knowledge systems e.g. Discoverant
• Able to speak, read and understand English.
Job Description
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
We have an exciting opportunity for you to join our new Biologics Protein Therapeutics Filling and Packaging facility based at the AZ Gartuna Site in Sweden.
The purpose-built facility will supply the next generation of biological drugs from the AstraZeneca pipeline; supporting the acceleration of the biologics portfolio. The new manufacturing plat will focus on the filling and packaging of protein therapeutics for late stage clinical and commercial products.
Our initial plan is to have the first clinical fills in Q4 2018 and first commercial fills in Q4 2019. On top of that we will be starting testing in our micro lab in 2017. In the long term, this site could create up to 250 highly skilled jobs. This site is intended to be the biologics site for late stage clinical and a vast amount of commercial products to increase the biologics manufacturing capacity and meet the needs of the maturing AstraZeneca pipeline. This newly build site will play a big role in our plans for the future.
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, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Publiceringsdatum2017-02-14Så ansöker duSista dag att ansöka är 2017-02-24
Ange följande referens när du ansöker: R-003685
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3318929
Observera att sista ansökningsdag har passerat.