Technical Support Owner - Qc

Technical Support Owner - QC
Irvine
9 months
£16.15 per hour - PAYE
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc, although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:
• Our values are Patient focus, Transparency, Respect, Integrity
• Our expectations are Courage, Accountability, Development, Teamwork
Job Purpose
• Provide analytical Technical Support to the Quality Control Department
• Ensure compliance with pharmacopoeia, internal regulatory procedures, technical standards and appropriate sections of the GSK Quality Management System.
Key Responsibilities
• Support the QC Lead and Shift Quality Leaders in the pursuit of zero defects by providing analytical expertise to continuously improve lab processes. Key deliverables include:
o Method development and training
o Instrumentation troubleshooting
o Change control ownership for lab equipment
o LIR improvements
o Analytical Tech Standards / Pharmacopoeia compliance
• Provide support to the QC Team in meeting appropriate GMP and EHS Standards which include:
o GLP
o Level 1 Audit
o COSHH
o WRA
• Liaise, communicate, interact with: Team Leaders, Lab Scientists, QP, Pharmacopoeia Group,
• External Experts, ATS Committee, Appropriate Shared Service Function (e.g., 3rd party support, source change, PPR’s)
• Ensure compliance with relevant Analytical Tech Standards / Pharmacopoeia through gap analysis and risk assessment as well as co-ordination of analytical work with in-house or 3rd Party groups.
• Ensure that all local SOPs reflect the relevant details / expectations as detailed in the Analytical Tech Standards, as required.
• Support review of QMS Gap Analysis and implement subsequent action plans.
Educational Background
• Degree or equivalent in an appropriate scientific discipline
Area of Specialisation
• Analytical chemistry or equivalent
Experience required
• Knowledge of GLP/GMP, Statistics, Analytical Validation, Regulatory & quality issues (preferably to MHRA standards).
• Practical laboratory experience
• Expert knowledge of pharmacopoeia, Analytical Tech Standards and GSK Quality Management System
• Resilient, highly accountable, drives for results, disciplined,
• Knowledge of statistics IT packages
• Good knowledge and experience of laboratory skills and ways of working e.g. High Performance
• Liquid Chromatography, Gas Chromatography, Atomic Absorption, Infra-Red Spectroscopy,
• RAMAN spectroscopy etc
• Demonstrated application of Continuous Improvement tools and techniques
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
Join GSK’s vision to do more, feel better and live longer:
https://user/gskvision/
Who will I be working with?
http://en-gb/careers/meet-our-people/