Novartis

Pharmaceutical

AS&TExpert

€61k+ Schaftenau, Austria FULL TIME Remote Friendly
The Brief

“AS&T Expert at Novartis. Skills: Analytical method transfers, Stability studies, Life-cycle management of analytical methods, Method performance control, Analytical method validation, Pharmacopoeia and health authority compliance, Method improvements, Handling of deviations, Investigation of OOS/OOE/OOT cases, Change control, Complaint handling, GMP requirements implementation. Coordinating and managing analytical activities across products. Managing customer-related projects and innovative Nova”

Industry & Context.

Pharmaceutical
Problems you'll solve

Problem Solving Skills; Handling of deviations; Investigation of OOS/OOE/OOT cases

Eligibility Requirements

Person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections

What They're Looking For.

Must Have

University degree or FH with natural science/technical background (e. g. chemistry, pharmacy, biology) or equivalent education, Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment, MS Office- and other standard IT applications, Fluent in English and German

Nice to Have

Skills Desired: Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

What You'll Do.

Coordinating and managing analytical activities across products

Managing customer-related projects and innovative Novartis initiatives

Providing scientific analytical expertise and support

Coordination and management of analytical method transfers and stability studies

Presentation and discussion of analytical data in local and international project teams

Life-cycle management of analytical methods

Handling of deviations

OOS/OOE/OOT cases as well as changes and complaints

Compilation and Review of documents (analytical protocols and reports

annual performance quality reports

ongoing process verification reports

registration documents)

Budgeting and cost control of external analytical activities

Management of reference substances and control samples

How You'll Work.

Team & Collaboration

Presentation and discussion of analytical data in local and international project teams; Cross-functional interface with Manufacturing Science & Technology team, analytical development, production, quality assurance and regulatory department; Person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections

Communication Scope

Presentation and discussion of analytical data; Communication Skills

Process & Methodology

Coordination and management of analytical method transfers and stability studies, Budgeting and cost control of external analytical activities

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