Solution Preparation Manager

1. Responsibilities

2. Provide leadership, coaching and training to the team.
   
   

3. Accountable for team development and performance review.
   
   
4. Accountable for solution (Buffers and Media) preparation for drug substance manufacturing according to GMP.
   
   
5. Accountable for the validation of solution preparation, cleaning and component sterilization of production equipment and facilities.
   
   
6. Accountable for execution of production projects and completing production plans on time.
   
   
7. Accountable for team's accurate and timely documentation records in accordance with GMP requirements.
   
   
8. Manage human and material resources to meet production targets
9. Lead in drafting/reviewing/revising SOPs, URS, PQ protocol, MBR and other documents
10. Lead and drive continuous improvement program.
    
    
11. Lead and support all internal and external audits.
    
    
12. Accountable for deviations and change control management.
    
    
13. Strong collaboration across functionally and perform other tasks as assigned by leadership.
    
    

Requirements

• Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; minimum 10 years' experience or candidates with equivalent work experience will also be considered.
  
  
• Ability to adapt to a GMP cleanroom environment, including the requirement to perform gowning and degowning.
  
  
• Possess strong communication and comprehension ability.
  
  
• Display strong working attitude, strong work ethic, and team collaboration.
  
  
• Be flexible and ready to work shift on need basis
• Be open to accepting temporary work assignments and other roles as required.