Laboratory Analytical Scientist (East London) at Aspen Pharma Group

Overview

• Lead scientific investigations in QC Lab
• Develop systems and processes for conducting investigations within GMP requirements
• Evaluate analytical equipment and techniques
• Reduce on Laboratory OOS with effective Preventative Actions
• Improve efficiency by reducing repeats
• Trend and analyse OOS data to identify improvements

Requirements

Responsibilities

Planning and Operational Support

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
• Determine, request and allocate assets and resources for fulfilment of work objectives, and monitor its use
• Apply advanced understanding of area of specialisation
• Analyse concepts and suggest streamlined procedures
• Identify training needs of QC staff 

Deviations Investigations

• Lead all scientific investigations within the QC Lab
• Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs
• Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
• Implement plans to reduce and mitigate OOSs
• Perform impact and risk assessments of CAPA plans on process compliance 

Reporting and Record-Keeping

• Compile complex reports and documents according to GMP requirements
• Update records and systems as required
• Ensure that recordkeeping complies with legal requirements
• Monitor and control access to databases in area of responsibility

Skills Required

Background/experience

• Post Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 2 to 4 years’ related experience
• Experience in quantitative and instrumental analysis in QC laboratory environment

Specific job skills

• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills
• Understanding of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights

 Accountability & Decision Rights 

• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
• Integrate resources for an area
• Escalate highly complex problems or out-of-policy issues

Decisions relating to:

• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
• Establishing own work priorities and timelines
• Interpretation of policies, standards, requirements and approaches

 Deliverables

• Deviations, OOSs and other nonconformities investigated and reported
• Laboratory OOS reduced
• Investigations performed according to regulation and standards
• All deviations reported
• Plans implemented to address, reduce and mitigate deficiencies
• Record-keeping complies with legal requirements
• Data integrity and access to systems controlled

Innovation, Creativity & Problem solving

• Identify and lead opportunities to enhance staff productivity and operational processes, tools and services
• Demonstrates creativity and initiative to problem solve and improve results
• Apply advanced interpersonal and problem-solving skills
• Regularly contribute actionable ideas