AS&T Hub Specialist

Major Accountabilities:

• Ensure that Novartis and Health Authority requirements concerning the AS&T Department are fully met.
• Execute the main activities in accordance with established SOPs and laboratory rules.
• Fulfill responsibilities assigned by the AS&T Manager accurately and in a timely manner, in conformance with methods, procedures, and workflows.
• Stay up to date with global analytical method development studies, current guidelines, and pharmacopeial requirements.
• Routinely assess testing monographs and proactively ensure compliance of all activities with current official regulations, pharmacopeias, QM, GOP, and SOPs.
• Evaluate and implement new technologies required to maintain state-of-the-art analytical methods for both development and marketed products.
• Execute analytical method development, method transfer, pre-validation and validation studies, and comparative dissolution analyses.
• Ensure right-first-time execution in all analyses and documentation.
• Prepare the related CTD documents for updated testing monographs.

Minimum Requirements

• BSc or MSc degree in Chemistry, Pharmacy, Chemical Engineering, or a related field.
• Minimum 2-4 years of experience in an analytical/QC laboratory, preferably within the pharmaceutical industry.
• Hands-on experience with analytical techniques such as HPLC, GC, TLC/HPTLC, UV and dissolution testing.
• Knowledge of cGMP& cGLP and basic SAP
• Experience in analytical method validation and/or method transfer activities is an asset.
• Familiarity with regulatory documentation (e.g., CTD sections, testing monographs) is a plus.
• Ability to work in a fast-paced changing environment
• Team working and customer-oriented mindset
• Good analytical thinking skills
• Strong interpersonal written and verbal communication skills
• Proficiency in MS Office; experience with LIMS, Empower, or Minitab is an advantage.
• Good command of English is required
  

Work Experience

• Sound technical & scientific knowledge of pharmaceutical/ chemical
• analytics/QC/R&D/ equivalent.
  

Skills

• Communication Skills.
• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gxp.
• Industry Standards.
• Laboratory Equipment.
• Laboratory Excellence.
• Self-Awareness.
• Technological Expertise.
• Total Quality Management.
  

Languages

• English.