To perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D.
· Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D
· Assure products meet regulatory requirements and that they conform to regulatory submissions.
· May interact with regulators.
· May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
· May lead a project, program or team activities which may include GxP.
· May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports.
· Identify business or reputation risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
· Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
· Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
· May represent the group as a primary business contact for specific areas.
· Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.
· Liaise with customers to provide compliance advice/input.
· Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
· Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs.
· Communicate and interact at various levels internally and externally to GSK.
· Build and maintain effective internal GSK business relationships within business units.
Specific Accountabilities that may be performed based on training:
· Approve GMP documentation, including Standard Operating Procedures, validation documentation, change controls, and other controlled documents from business partner areas.
· Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
· Perform internal assessments to measure compliance with appropriate GSK policies and procedures.
· Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
· Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment procedures.
· Initiation and maintenance of Quality Assurance Agreements
· Develop and deliver GxP training to business partners.
· Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
· Generate, review and approve batch and/or packaging record templates.
· Conduct review of completed batch and/or packaging records.
· Perform material release activities (US Only)
· Ensure that the third party assessments are available to support material release
· Generate and approve relevant release documentation
· Provide project support including pre approval audit activities.