ProClinical have a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Quality Compliance Administrator to join their team at their Cambridgeshire UK offices. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation.
- Research Quality Assurance activities undertaken in support of clinical research projects across multiple therapeutic areas.
- Pharmacovigilance Quality Assurance (PV QA) activities undertaken in support of products used in clinical studies.
- To ensure that RQA and MR activities undertaken on site and at IAC and/or contract organisations follow regulatory guidelines.
- Act as the process owner for GxP tracking system and assist with management of documentation for GxP alerts and tracking of associated CAPA's.
- Act as process owner for CAPA system. Enter CAPA's into system and track to completion and obtain and file objective evidence where applicable. Where required, perform effectiveness checks to determine whether CAPA's have been successfully implemented.
- Assist in the production and review of RQA quality system SOP's.
- Support PV audit team with information required for provision in the PSMF.
- Assist with audit planning and maintenance of the RQA Audit Schedule.
- Facilitate outsourcing of audits, including liaising with contract auditors.
- Facilitate the generation and maintenance of MSAs for all RQA consultants
- Drafting work orders
- Audit scheduling
- Providing applicable RQA SOPs for consultant auditor sign off;
- Maintenance of consultant’s log and consultant auditor records.
- Following the conclusion of an audit enter the agreed responses into the CAPA system and track to completion. This will involve liaising with the audit response owners and requesting/obtaining objective evidence for completion of actions where applicable).
- Assist with generation of audit metrics for reporting to MR and RQA management on a routine basis.
- Assist team with travel management, including requesting relevant approval, visas and liaison with MINT nominated travel company.
Skills and Requirements:
- Experience of working in the pharmaceutical industry; preferably within an R&D environment.
- Experience of working within small teams.
- Ability to plan, organise and monitor activities according to priorities.
- Good IT skills and familiarity with standard MS office package.
- Effective communication skills - written and verbal.
- Ability to effectively manage own time and workload to meet defined milestones and deadlines.
- Ability to analyse problems with an open mind.
- Attention to detail, patience and a logical approach to problems.
- Understanding of the GxP terminology and how the different GxPs relate to the different areas within Pharmaceutical Research and Development.
- Understanding of the reasons behind and requirements for reporting GxP issues within Quality Management Systems.
- Understanding of the purpose of a CAPA system and how this relates to GxP issues, inspections and audits.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.