Validation Lead at AstraZeneca
Dfind Science & Engineering AB / Kemiingenjörsjobb / Göteborg
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We are now looking for a Validation Lead to Drug Product Manufacture for a 12 months consultant assignment at 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.
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.
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-10-11. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Eleonor Ehrman 073-343 41 09 or Kerstin Karlsson
kerstin.karlsson@dfind.se.
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-10-05ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-10-15
Ange följande referens när du ansöker: 201177490
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman 073-3434109
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41110 Göteborg
KontorsadressSödra Hamngatan 35, 41110 Göteborg
Jobbnummer 4386740
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