JOB OVERVIEW

Support through effective execution the following critical quality systems:

• Audits
• Vendor Qualification
• Annual Product Quality Review

REQUIREMENTS

Minimum 5 years of experience in a GMP regulated environment in a quality assurance or quality compliance role

• University Degree in a related science
• Demonstrated problem solving skills

RESPONSIBILITIES

. * Suggest improvements to the quality systems, reducing their complexity while maintaining compliance to GMPs.

• Assess CAPA actions to determine their effectiveness
• Initiate change management processes applicable to changes in quality systems and facilitate closure through effective execution of deliverables and full implementation of proposed changes.
• Initiate and/or own CAPA processes applicable to quality systems.
• Initiate document control processes applicable to changes to documents associated with quality systems.
• Prepare/review Annual Product Quality Reviews on-time and per customer and regulatory requirements.
• Maintain vendor/supplier qualification program by gathering information to support approval and certification of vendors.
• Where required, lead internal and external vendor audits (vendor qualification), prepare audit reports and complete audit follow up. Page 2 of 2
• Participate in customer and/or regulatory audits in varying capacities as required.
• Other duties, as assigned.

Minimum 5 years of experience in a GMP regulated environment in a quality assurance or quality compliance role

• University Degree in a related science
• Demonstrated problem solving skill