Quality Assurance Specialist

• Complete review and approval of site documentation
• Supports the site compliance plan and quality metrics generation
• Leads walk down and scheduled audits
• Participate in the preparation for and hosting of regulatory and customer audits
• GMP training delivery to site personnel
• Investigation of Supplier Complaints / Raw Material Deviations / Customer Complaints
• Provide Quality support to Deviation and Laboratory OOS investigation.
• Provide Quality guidance to Operating procedure review and approval
• Provides support to Process and Validation review
• Generation of Technical & Quality agreements
• Generation of Annual Reviews and Product Quality Reviews
• Participate in Quality and site projects that may arise.
• Production batch record review pre and post production
• Clinical and development support Deviation and OOS investigation support

• Minimum of Degree in Science, Pharmacy or Engineering.
• Qualifications as Qualified Person in accordance with Article 49 of Directive 2001/83/EC is an advantage but not required.

• MMD and site quality policies, procedures and guidelines
• Relevant GMP standards
• The Quality System
• Site procedures and policies
• Site equipment, layout, documentation
• Laboratory testing and documentation
• Validation
• Understands key business drivers and uses this knowledge to make decisions and prioritise

• Computer Applications: Word, Excel and Email Management.
• Meetings Management
• Communication skills both written and oral including persuading others
• Technical report writing
• Time management
• Analytical Problem solving skills applied to issue identification and resolution
• Continuous improvement skills:
• Interpersonal Team membership and leading Skills e.g.: Listening, integrating diverse
• perspectives, adds value to the achievement of team goals.
• Responds to non-standard requests
• Supports cross functional investigations
• Timely decision making.

Morgan McKinley