Lediga jobb Experis Engineering i Södertälje

Experis Engineering is looking for a QC Microbiologist for consultant-position for our client AstraZeneca in Södertälje. Are you fluent in both Swedish and English as well as have the required qualifications, please apply to us today. We look forward to receiving your application!

Do you have expertise in, and passion for, Microbiology? Would you like to apply your expertise in brand new laboratories with the highest technology, in a company that follows the science and turns ideas into life changing medicines?

Then AstraZeneca's new BioManufacturing Center in Södertälje might be of interest to you, we have an exciting opportunity for a QC Microbiologist to join our new plant!

At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

AstraZeneca's "production heart" in Södertälje, is one of the world's largest manufacturing units for pharmaceuticals. Here, we thrive in a high-tech and LEAN-based environment where we value collaboration, improvement work and smart solutions highly.

The new BioManufacturing Center will supply the next generation of biological drugs from the AstraZeneca pipeline; supporting the acceleration of the biologic portfolio. The new manufacturing plant will focus on the filling and packaging of protein therapeutics for late stage clinical and commercial products.

Your role

As a Microbiologist you will be a critical key player in performing laboratory tests in accordance cGMP to produce reliable and precise data to support product release and scientific investigations.

You will also be instrumental in supporting production activities such as environmental monitoring of classified areas. What we ask from you is also to lead by example and acts as a role model according AstraZeneca values and behaviours



Examples of the analytical methods that you will be working with:

* Identification of microorganism by a state of the art MALDI-TOF system
* Product release testing of endotoxin analysis using singe use cartridge technology
* Microbial Bio-burden of water using a Rapid Microbiological Method based on solid phase cytometry
* Perform growth promotion tests on microbial growth media
* Cultivate and read Biological Indicators to ensure that disinfectant and sterilisation processes are in place

As a QC Microbiologist you will also be working with:

* Write and execute SOPs and reports and keep up to date with technical developments
* Perform data review/approval and data retention activities. Input data for trending purposes
* Perform a variety of non-routine testing including analytical method transfer and validation, experimental/validation work and analytical support to production
* Work with improvements of established processes using LEAN as key philosophy
* Provides support to functional and cross functional investigations when needed





Essential Requirements

* Fluent in both Swedish and English, both verbally and in writing
* Master's degree or equivalent in Microbiology
* Experience in a Good Manufacturing Practice (GMP) environment / Good Laboratory Practice (GLP)

* Good understanding of Quality Control testing techniques and Previous Biopharmaceutical Industry experience or equivalent



Why AstraZeneca?

When we at AstraZeneca see the chance to change, we take this opportunity - for every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.

We are therefore looking for you, who together with your team will make a difference for patients' lives every day. AstraZeneca welcome your positive attitude and your desire to develop both yourself, your team and the department

You will get use for your drive and your ability to work carefully and structured even at a high tempo.

Are you ready to make a difference? Send in your application, and we'll make it happen together!



Experis Engineering can offer you:

Experis Engineering is in a growth phase, which means you have a big influence on working methods, personal development and career. We have access to the most exciting customers and assignments in a variety of industries - which gives you a great opportunity to build up your knowledge and networking in the field of engineering!

As a consultant at Experis, your personal Consultant Manager will support you in ensuring that you receive the assignments, training and coaching needed to grow as a person and as a professional consultant.

How to apply?
Please submit your application at www.experis.se. We will evaluate the applications ongoing so please apply as soon as possible. The position might be filled before last application date. We are looking forward to receiving your application! Please note that we can't accept applications via e-mail. If you have any question, please contact [email protected]. Visa mindre

Are you a natural leader, have experience in Quality Assurance and GMP and are ready to take the next step? Experis Engineering is looking for a Quality Supplier Manager (SQSM) to work as a consultant on a consultant mission for AstraZeneca from 2020-01-07 to atleast 2020-10-30. Welcome to apply!

At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

The new Global Supplier Quality (GSQ) organisation is an evolution of the AZ Global External Sourcing (GES) Quality team, combining global and local supplier management across the AstraZeneca Operations network.

GSQ provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations. The scope of the organisation includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.

This is a diverse and interesting role working with the Suppliers and contractors and also with GES colleagues and customers across many countries and interacting cross-functionally with supply chain, supplier relationship, technical and project roles. Some travel is required along with a high level of independence for the role.



Key accountabilities:

You will be responsible for assuring the quality of material received by AstraZeneca from the designated supplier portfolio by applying GES supplier management processes. This will include managing and escalating, where appropriate, any Quality Systems oversights, product quality complaints and deviation investigations.

You will drive quality improvements at the supplier as part of a cross function team.

Managing the quality aspects of major changes at the supplier including any technical improvements, regulatory interactions, supporting inspections and site transfers.

This role will require national & international travel



Essential skills:

* Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering or equivalent experience
* Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
* Excellent oral and written communication skills
* Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
* Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
* Strong problem solving skills
* Strong negotiating/influencing skills
* Ability to work independently under your own initiative.
* Ability to travel nationally and internationally as required up to approximately 10% of their time.

Desirable skills:

* Experience working in a PCO/PET organization or Lean/Six Sigma training.
* Multi-site / multi-functional experience - particularly within a manufacturing site environment.
* Proven experience in Quality Assurance or combination of Quality and Technical.
* Master's Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field.



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.



What we offer our consultants at Experis

As a consultant at Experis, we offer you the opportunity to develop your skills on behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.

Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement



Application

Unfortunately, we can not receive your application by email, but apply through the application field through this advertisement. The selection process is ongoing, so it's important that you submit your application as soon as possible.

If you have questions regarding the consultancy role you are welcome to email Talent Acquisition Specialist Viktoria Vershovsky at [email protected]

Welcome with your application! Visa mindre

Are you fluent in both Swedish and English, have a chemistry degree and experience in quality management in a pharmaceutical company or pharmacy, look here! Experis engineering are now looking for a consultant to a role as a Regulatory CMC Associate at AstraZeneca. Welcome with your application!

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.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.

We are now looking for a Regulatory CMC Associate.

This role is available as a temporary contract and will be based in Södertälje, Sweden.

The role

The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions to obtain information that supports the generation of regulatory documentation.

You may also coordinate assembly of submission-ready documents to support lifecycle submissions.

You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.

You may also support externalisation projects and transfer of CMC documentation to external partners.

The role will be based in Södertälje and you will work in a team of 8-10 people.



Minimum Requirements - Education and Experience

* Degree in Chemistry or Pharmacy or Chemical Engineering
* Fluently spoken and written English and Swedish
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
* Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable



Skills and Capabilities

* Able to work collaboratively with customers and colleagues to achieve optimum outcomes
* Knowledge of information and document management technology and electronic/paper publishing software
* IT software skills
* Ability to work with short and/ or changing timelines
* Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others

* Excellent written and verbal communication skills



What we offer our consultants at Experis

As a consultant at Experis, we offer you the opportunity to develop your skills on behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.

Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement



Application

Unfortunately, we can not receive your application by email, but apply through the application field through this advertisement. The selection process is ongoing, so it's important that you submit your application as soon as possible.

If you have questions regarding the consultancy role you are welcome to email Talent Acquisition Specialist Viktoria Vershovsky at [email protected]

Welcome with your application! Visa mindre