• Review and approve policies & SOP’s, ensuring that corporate, site and regulatory requirements are met
• Perform review and approval of validation documentation
• Lead and participate in internal audits, external audits as needed
• Support sites during European regulatory inspections by personal attendance if required
• Maintain a close contact and familiarity with systems and programs utilized at sites
• Own, review and approve non-conformances & capa’s, ensuring all procedural and GMP requirements are met
• Provide guidance and direction to quality, production and warehouse/distribution staff in regards to compliance with quality policies, standards and procedures
• Act as quality assessor and approver for change requests. Act as a quality representative in change control review board
• Participate in global quality initiatives ensuring the ELC input is provided and leading ELC implementation activities
• Participate and Lead in various ELC projects and improvement efforts including “new” product launch teams
• Act as owner for ELC quality programs and procedures
• Act as a quality assessor in ELC quality complaints
• Act as quality contact in case of regulatory inspections or various questions from regulatory bodies
• Product disposition
• Perform quality agreement approval
• Perform QP assigned tasks during recall activities
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