Under guidance of Supervisor, responsible at project level for all activities in AR&D-Test Centre including method validation for new products, testing of PI, in-process, stability samples and finished dosages, and generating regulatory submission documentation. Acts as a key member in the project working team and provides support to junior chemists. Also, oversees lab activities in absence of Asst. Manager.

Job Responsibilities

• Performs validation of analytical testing procedures for drug substance and drug product
• Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance with laboratory SOP and guidelines.
• Performs routine tests for drug substance release, drug product release , stability samples and in-process samples. .
• Conducts lab investigations for OOS and OOT results.
• Conducts other tests required for regulatory submissions.
• Guide junior chemists in complex testing and investigation
• Documents and reports results as per established SOP’s.
• Provides technical support to other department in response to deficiency letters from regulatory agencies
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health and Environment policies, and HR policies.
• Develops and manages strong relationship with internal customers.
• Liases at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and to understand their needs.
• Refers more contentious issues, with recommendations, to Supervisor
• Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
• With guidance from supervisor, performs trouble-shooting on complex issues
• Oversees the resolution of more complex issues related to the project.
• All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  • A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Sound working and theoretical knowledge of chromatographic systems
  • Knowledge of UV, IR, wet chemistry, potentiometric titration, analytical bench techniques, Window-based software, and automated data acquisition systems.
  • Knowledge in HPLC method development and method validation.
  • Excellent written and verbal English communication skills.
  • Leadership skills are an asset.
• Experience
  • BSc with 10 years or MSc with 8 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment.

Exigences liées au poste