Job Description

Purpose

• Provide high quality scientific and analytical expertise for solid dose, liquid and injection pharmaceutical products
• Execute activities related to process and /or product improvement activities in the manufacturing locations throughout the network of companies
• Deliver on product lifecycle activities that would enhance the product portfolio to maintain commercialisation footprint and products on the market
• Ensure manufacturing department are supported in their day to day operations with relevant deviation and process improvement oversight
• Seek out improvement opportunities and make suggestions to management for changes in practice and technical innovation
• Subject matter expert on selected projects

Accountabilities

• Support analytical method activities between sites and laboratories
• Support analytical validation strategies
• Ensure all aspects of analytical development and validation are delivered to the required standard of science, quality and regulatory compliance in accordance with agreed timelines
• Assist with Quality Management System processes such as Change Controls, Deviations, CAPAs and Quality Risk management procedures
• Support Analytical investigations
• Plan, coordinate and conduct laboratory work to support analytical projects, this can be including analysis of raw materials, intermediates and finished products
• Record, evaluate and present data generated during laboratory work
• Be proficient and proactive in the use of regulatory and other relevant guidelines, including pharmacopoeias, to ensure appropriate compliance within projects

Team and Personal Development

• Support and develop other members of the Analytical Service Team
• Commit to personal development and training needs
• Support the process of continuous improvements with the aim to reduce cost, improve quality and increase efficiency
• Work in a team spirit to further drive the function and business needs
• Maintain accurate and up to date training record
• Continually develop and expand on technical and scientific knowledge

 General

• Ensure compliance with statutory duties, regulation and legislation. Ensure activities meet with and integrate with organisational requirements for quality management, health and safety, legal, Code of Business Ethics
• When appropriate to the function create, revise and maintain up to date Standard Operating Procedures
• Ensure compliance with GxP

Required Knowledge, Skills, and Abilities

• Ability to prioritise multiple expectations and work in a fast-paced environment
• Report writing & strong oral communication
• Handling and interpretation of data
• Strong attention to detail in composing and proofing materials
• Good time management and organisation skills
• Strong ethical standards and a high level of personal integrity
• Professional, forward thinking, enthusiastic and highly motivated

• Significant industrial experience working in or maintaining a GMP/GLP compliant analytical environment
• Experience with EU regulatory guidelines
• Understanding of ICH guidelines
• Understanding of Quality management systems and quality risk assessments