Description

The role will offer the successful candidate a unique opportunity to work as part of a team across API and Drug Product in the development, clinical and commercial businesses.

Responsibilities will include

• 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

The position will provide an opportunity to develop strong Quality and Technical understanding of Operations and Compliance requirements in the Pharmaceutical Industry.

Qualifications

Education Requirements

• 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.

Core Competencies
Knowledge:

• 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

Skills:
Must possess a high standard of knowledge and skills in the following areas:

• 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.