Quality Manager

Quality Manager 

• Validation Activities: Provides QA support in validation strategy meetings related to facility, utility, automation, equipment and QC Lab operation activities.
• Change control: Provides QA support on change controls.
  • Leads and manages change control proposal meetings.
  • Reviews for execution approval of change controls per change control SOP.
  • Performs final review and approval of change controls..

• Performs QA changeover requirements and maintains documentation.

POSITION REQUIREMENTS:

• Strong knowledge of 21 CFR, ICH, and EU regulations
• Strong knowledge of Risk Based approach and performing Risk Assessments
• Strong interpersonal and communication skills and the ability to work effectively a diverse community.
• Proficient at public speaking and teaching
• Recognize, understand and respond to situations
• Understand operational documents for GMP compliance, accuracy and completeness.  
• Function in a dynamic environment and balance multiple priorities simultaneously.

EDUCATION AND QUALIFICATIONS:

• Bachelor’s Degree in Sciences or Education
• Minimum 8 years’ industry related experience with a Bachelor’s Degree
• Strong interpersonal and communications skills; written and oral
• Solid understanding of applicable regulatory requirements