Our client are a major pharmaceutical business who are looking for an Analytical Compliance Officer to join their Analgesics team on a 12 month fixed term contract
Responsibilities:
Supporting the Analgesics category in the area of data compliance, GMP, data checking and integrity
Checking of analytical data packages
Identification and reporting of out of specification and out of trend / anomalous results
Ensuring consistency, accuracy and quality of GMP critical data
Logging out work packages
'Live' checking of laboratory work
Recording and reporting Key Performance Indicators
Identifying and implementing key training procedures and proactively addressing and delivering improvement to working practices
Proactively contribute to the continuous improvement of the analytical function with respect to new analytical technologies, procedures and/or processes
Contribute to healthcare innovation by challenging current perceptions and practices
Supervise and coach members of the team, as required.
Ensuring compliance and consistency across a large number of staff across three teams.
Working in a challenging, fast paced environment, on varied projects.
Produce work of the highest quality in accordance with the relevant regulatory guidelines to challenging time scales.
Experience:
Experience of working in a GMP healthcare / pharmaceutical analytical laboratory testing a variety of drug substances/drug products.
Working to current GMP's and ensuring data compliance
Understanding of and ability to identify out of specification and out of trend results
Working knowledge of HPLC, dissolution, Karl-Fischer analysis, Empower software, general analytical techniques as a minimum
Working knowledge of stability studies and method validation in accordance with ICH guidelines
Experience of regulatory compliance and the Common Technical Dossier (CTD) would be beneficial
Please note that this position is a 12 month fixed term contract
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.