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438 Sandoz Jobs

AS&T Expert - Quality Operations

10-14 years

Hyderabad / Secunderabad

1 vacancy

AS&T Expert - Quality Operations

Sandoz

posted 5mon ago

Job Description

Job Description Summary
The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well as to provide scientific analytical support.

 
About the Role:
The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well as to provide scientific analytical support.
Key Responsibilities:
  • Coordination and management of analytical method transfers and stability studies. Compilation of data reports.
  • Compilation of Quality control monographs describing test procedure and specification setup.
  • Scientific analytical support for quality control, production, registration, marketing.
  • Presentation and discussion of analytical data in local and international project teams.
  • Life-cycle management of analytical methods, including control of method performance, pharmacopoeia
  • and health authority compliance and definition of method improvements. Handling of deviations,
  • investigation, OOS/OOE/OOT cases as well as changes and complaints.
  • Cross-functional interface with Manufacturing Science & Technology team, analytical development, production and regulatory department.
  • Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives.
  • Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
  • Budgeting and cost control of external analytical activities.
  • Contribution to QC/AS&T network teams.
  • Management of reference substances and control samples.
Essential Requirements:
  • Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications.
  • External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation.
  • Innovation: continuously thrives for improvements and questions processes and procedures for improvements.
  • Reacts in a flexible and fast way on changes and challenges.
  • Ability to analyse complex processes.
Desirable Requirements:
  • Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.
  • Language proficiency: English, German optionally.
Skills Desired
Continuous Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Employment Type: Full Time, Permanent

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