Group Expert Analytics Method Validation M/F - Group QC Method Validation III - Lifecycle - CDI

Octapharma; Lingolsheim; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Octapharma, un leader dans la production de médicaments à base de plasma humain, recherche un Spécialiste Analytique à Lingolsheim. Le candidat idéal aura un diplôme en chimie ou biosciences et une expérience dans la validation de méthodes. Ce poste implique le développement de méthodes, la préparation de documents de validation, et le support des opérations QC. Rejoignez une équipe passionnée par la qualité et la sécurité des produits pour les patients.

Prestations

Canteen avec repas locaux

Formation interne et externe

Bonus d'incitation et partage des bénéfices

Micro-crèche d'entreprise

Activités sportives et événements annuels

Qualifications

• Expérience dans l'industrie pharmaceutique, surtout en validation de méthodes (environnement GMP) est un plus.
• Compétences en communication en anglais et en français (oral et écrit).
• Capacité à multitâcher avec un haut niveau de flexibilité.

Responsabilités

• Développer et valider des méthodes.
• Préparer des documents de validation et d'autres documents pertinents pour le GMP.
• Supporter le dépannage dans les laboratoires QC.

Connaissances

Résolution de problèmes

Gestion du temps

Compétences en communication

Flexibilité

Formation

Diplôme universitaire (MSc, PhD ou équivalent) en chimie/biosciences

Outils

MS Word

MS Excel

Description du poste

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Group Expert Analytics Method Validation M/F - Group QC Method Validation III - Lifecycle - CDI

Job ID: 59995

Location:

Lingolsheim, FR

Job Level: Professionals

Job Category: Quality

Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma Lingolsheim, a booming production site, is growing and investing in numerous projects every year.

What will you be doing as Analytical Specialist ?

• Develop and validate methods
• Prepare validation documents and other GMP relevant documents with support of senior analytical specialists and team leaders
• Support troubleshooting in the QC laboratories
• Sample administration and follow up of the validation related testing in the QC and R&D laboratories
• Support of method transfer and issue/update of product specifications
• Administrate documents required for submission and support within inspection tasks
• Preparing statistical evaluation of data and reporting in Excel
  

Who you are ?

• University degree (MSc, Phd or equivalent) in chemistry/biosciences
• Work experience in pharmaceutical industry especially in the field of method validation (GMP environment) is a plus
• Willingness to travel due to business trips
• Good knowledge in MS Word and MS Excel
• English and french communication skills (oral and written)
• Social skills and presentation skills
• Strong problem solving, organizational and time management skills
• Ability to multitask and a high level of flexibility
  

The Corporate QC Method Validation Department :

• Main mission : as Subject Matter Expert for analytical methods supporting QC Operations and ensure regulatory compliance of used methods
• cQCMV III is a team of 7 employees (part of cQCMV)
• Working closely with all manufacturing sites and other corporate functions (QC Operations, R&D, IDRA, Operation support)

« cQCMV is a high motivated and skilled team working hand to hand with the manufacturing sites and other corporate functions to succeed in the challenges from both routine production and strategic projects for the group. We are a big family, driven by our passion for high quality of release methods, with always in mind making the best of our high valued protein material – don’t lose a drop! - and delivering high quality products for our patients.»

Become part of a vital chain

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Skills development - We offer various internal and external employee and leadership trainings and digital solutions
• Complete integration course upon your arrival: different modules, visits, and a game that will provide you all the necessary informations for your integration
• Located in city center: auto/motorcycle/bike parkings, ecomobility agreement
• Company canteen: 7d/7 breakfast/lunch/dinner, local products cooked on site, partial coverage of meal costs
• Active company life: awareness days, theme weeks, annual event, ...
• Dynamic Work Council: preferential ticket prices, sports activities, vacation vouchers, children's Christmas party, ...
• Company micro-nursery
• Incentive bonuses and profit-sharing
• Attractive health insurance
  

Would you like to get to know us better?
Learn more about us on our website and follow us daily on LinkedIn !

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.