Senior Quality Assurance Auditor GCP
Major CRO Based in Berkshire
Excellent Salary and Benefits
My client is a leading CRO. With offices around the globe, and across six continents, their UK office is located in Berkshire, and is within easy reach via major transport links.
The goal of our client is simple - to assist their customers to develop products for patients more quickly and cost effectively. Offering support in a full range of phase I to IV clinical development^services , their broad therapeutic expertise affords the development of innovative solutions to accelerate the delivery of life changing products.
With over 5000 employees worldwide, and working with 90% of the world's top 50 biopharmaceutical companies, it is essential that my client has the best staff - and that's where you come in.
Conducts and documents assigned audits of the projects and operational processes in accordance with approved procedures, schedules and formats.
Specific audit areas will include but not be limited to:
Trial Master and Site files
Project Databases (and their development)
Data Management Activities and documentation
Staff Training Records
Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management. Reviews responses to audit findings for appropriateness and completeness.
Maintains documentation and status of QA auditing activities as outlined by applicable SOPs and WIs. Serves as a mentor to less experienced QA Auditors.
Serves as^Lead Auditor on team-based audits and/or for project audits.
Manages assigned quality issues in accordance with Company requirements.
Hosts sponsor audits as assigned. Performs other work-related duties as assigned. Travel may be required (an^can be at least 50%), domestically and internationally
Essential Skills & Qualification
-Requires quality assurance auditing, including investigator site audits, audits of data management activities and vendor audits.
-Requires strong and comprehensive knowledge of applicable Good Clinical Practice regulations and Guidelines as well as medical terminology.
-Ability to handle multiple tasks to meet deadlines in a dynamic environment is a must.
-Strong organizational, presentation, documentation and interpersonal skills with diverse cultures needed.
-Ability to negotiate and provide constructive feedback is essential.
-Must be able to work as part of a team as well as independently.
-Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation.
-Proficient use of computer and Microsoft software programs and Email and voice mail communication systems is a must.
-Ability to work nights and week-ends as needed.
Software Competence: MS Office, MS Project, Zinc, INFORM or RAVE, IMPACT, DOCUMENTUM
Valid Driving License: Essential/Not Required
Working Language(s): English
Requirement for Business Travel: Yes/No
Flexible Working Hours: No/Yes/To be confirmed
Employment Type: Permanent
Hours: Full time
Location: Office Based access near M3/M4
Company Pension, Company Car, Car Allowance, Life Free gym, Relocation Assistance.
Quality Assurance, Audit, Inspection, CAPA, Findings, CQA, GMP, GCP, Qualified Person, QP, Clinical QA, Auditor, GCP Inspection, PVG Inspection
Assigned Consultant:Sue Spice at CSL Recruitment 01932 228928 or email@example.com
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.