Description:
This position is accountable for oversight, management, and delivery of all Validation Lifecycle components executed across Technical, Engineering, and QC departments at the site.
Role Responsibilities
- Understands and ensures compliance to evolving expectations of: Equipment and Facility C&Q, Process/Packaging validation, cleaning validation, Continued Process validation (CPV), Analytical Method validation, and Computer System validation
- Collaborates across Engineering, Quality and Technical departments to ensure validation activities are completed on time and compliant to Haleon standards
- Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., FDA, Health Canada, or ANVISA)
- Maintains site validation master plan (SVMP)
- As the site cleaning SME, maintains the site cleaning lifecycle process by assessing impact of new products, processes, or changes against the existing site cleaning matrix. Coaches and develops the technical team to ensure that cleaning validation execution demonstrates that the process produces the expected results in a reproducible manner, and that proper monitoring is in place to ensure the processes remain in a validated state of control
Why you?
Basic Qualifications:
- BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific major.
- Minimum of 5 years of demonstrated experience FDA regulated technical role, with strong experience in cleaning validation