Validation Lead - Drug Product Manufacture
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is looking for a Validation Lead for a consultancy assignment at AstraZeneca in Mölndal.
About AstraZeneca
AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. 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.
The Arena
Pharmaceutical Technology and Development is accountable for delivering the design along with innovative, efficient and robust processes for the manufacture of drug substance and product, the supply chain of products for safety and clinical trials and the generation of information and knowledge to ensure regulatory approval of new products.
Drug Product Manufacture (DPM) in Gothenburg manufactures prototype products (e.g. oral/inhaled solution/suspension, parenteral solutions, capsules, tablets and pellets) to AZ clinical studies around the globe. DPM is supporting a wide portfolio of projects across all AZ therapy areas. Establishing numerous new products annually, and with an overall supply of products to approximately 25 projects yearly, you will join a team that make an important contribution in delivering science for development and manufacture of new medicines.
We now have a temporary position in our team for one year, starting December 2018.
The Role
The role is technically advanced without any direct reports and a vital part of the network driving our GMP asset utilization and to bring in new technology. High validation standards with excellent documentation is key for our business. The role holder therefore has strong expertise/technical competence, credibility and ability to lead and plan, perform and provide advice validation activities with focus on manufacturing equipment but also related to facility and systems (all with GMP validated status). You will also be accountable for DPMs overall validation strategy and lifecycle procedures.
The role holder collaborates closely with internal and external partners ensuring compliance within the framework of GMP and SHE. An interest to drive continuous improvement of capabilities to improve our capacity and agility is expected.
The role holder also supports the preparation and actively participates during regulatory inspections at the Gothenburg site, providing evidence of our validation procedures and activities using relevant documentation.
Requirements
• MSc in engineering or equivalent experience in validation.
We are looking for a professional employee with high technical knowledge, documentation, change management and project leadership skills who has the ability to operate independently with good collaboration in a culturally diverse, complex and changing environment. The applicant should have a good understanding of development within the industry and how they impact the function.
You will have knowledge of cGMP and an appreciation of the principles, applications and management of Engineering, Automation and current Quality Management standards. Excellent documentation skills both in English and Swedish. An interest in manufacturing equipment and automated systems is essential.
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-10-05ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-13
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4386701
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