Product and Validation Lead

• Accountable for oversight, management, and delivery of all Validation Lifecycle components. Provides guidance and support on validation, in terms of standards, approach and execution. As the validation expert, supports internal and external audits ensuring successful outcome.
• 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 validation SOPs are compliant to Haleon Quality standards and GMP.
• Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., TGA, NPRA, FDA)
• Maintains and ensures site validation master plan (SVMP) adherence
• Identify quality risks in validation projects and supports risk mitigation. Facilitates validation Risk assessment and deviation investigation.
• 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

Qualifications & Skills: 

BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline.

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