Corporate Quality Control Method Validation Manager
Octapharma AB / Kemiingenjörsjobb / Stockholm
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hela Sverige Octapharma är Nordens enda tillverkare av plasmabaserade läkemedel. Vi har vårt ursprung i det svenska läkemedelsföretaget Kabi med mer än 60 års erfarenhet av forskning, tillverkning och försäljning av plasmabaserade och genteknologiskt framställda proteinläkemedel. Vår fabrik och vårt huvudkontor ligger på Kungsholmen i Stockholm. Vi är ca 620 anställda.
Octapharma is now looking for a Corporate Quality Control Method Validation Manager within cQC Method Validation to our office in Stockholm, Sweden.
Main task will be to lead the local department of cQC Method Validation and take share in enshrine successful cooperation in-between Quality departments. You will report to Head of cQC Method Validation in Vienna and to the Head of Quality in Stockholm.
About the job
• Personnel responsibility, lead and develop a group of five method validation specialists
• .In cooperation with the Head of cQC Method Validation in Vienna maintain and develop the method validation plan.
• Interface with other in-house departments to ensure that validation project plans are understood and kept with site objectives.
• Initiate and implement change control activities in accordance to procedures
• Lead daily operations and ensuring continuously improvement of our day-to-day process.
• Present validation system programs at internal and external audits as required.
• Preparation and communication of status reports.
• Write corporate SOPs and policies in accordance to guidelines, review and approve corporate documents.
• Develop and where appropriate deliver training regarding the method validation and metrics.
• Follow and secure that cGMP regulations are being understood and followed in all aspects of validation across manufacturing, laboratories and facilities
Relevant background
• BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
• More than 5 years' experience in method validation in a drug manufacturing company.
• Management and/or supervisory experience in a drug manufacturing company.
• Experience from working in a Lean organization and working with GMP.
• Fluent in Swedish and English
Personal characteristics
To be successful in this role we believe you have excellent interpersonal and communication skills combined with an ability to initiate and cultivate strong work related relationships on all levels of the organization. You are a natural leader who creates and maintain great structure in your work and take on your assignments with professionalism, integrity and a "can-do-attitude". You have patience, excellent analytical skills and good judgement. Moreover you have good knowledge of regulatory guidelines relating to process development and a sharp eye for method validation and quality measurements.
Your application
We offer you career opportunities in a modern workplace with challenging assignments and exciting projects. For questions regarding the position contact Martina Schwarz,
martina.schwarz@octapharma.com or/and Parivash Gunnerfält parivash.gunnerfä
lt@octapharma.sePlease note that we want you to fill out your application in the system
Our union representatives are Zahra Kafash-Hoshyar at Unionen, 08-56643313 and Tomas Mårtensson at Akademikerföreningen, 08-566 432 76.
This is a fulltime position based in Stockholm. We look forward to receiving your application before 20th of February. We want your application to be written in English.
Key facts about Octapharma
Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell-lines. Octapharma employs approximately 6,000 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders), Critical Care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. For more information visit
www.octapharma.comVaraktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-02-09ErsättningFast lön
Så ansöker duSista dag att ansöka är 2016-02-20
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Klicka på denna länk för att göra din ansökanKontaktCharlotte Rogeholt
FöretagOctapharma AB
AdressOctapharma AB
Lars Forssells gata 23
11275 Stockholm
KontorsadressLars Forssells gata 23
Övriga kontaktuppgifter Jobbnummer 2661599
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