- 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.
- 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