GxP Audit Manager
Location: SwitzerlandSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Zug Switzerland.
Our client is focused on Gastroenterology and other areas.
ROLE DESCRIPTION
Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external suppliers/ vendors/ service providers such as contract manufacturing organizations, suppliers of raw materials, laboratory operations, logistics providers, and GMP service providers.
RESPONSIBILITIES
Assembly and coordination of the audit team, preparation of the audit plan, leading the audit, writing audit reports and follow-up letters.
Ensure that the appropriate remediation/ CAPAs are in place for any GMP deficiencies found during audits.
Participation in vendor change notification assessments
Participation in creation and approval of vendor quality agreements.
Perform material/ vendor risk assessments
Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance at external vendors
REQUIREMENTS
Minimum 10 years related compliance or auditing experience in the pharmaceutical and/or biotechnical arenas.
Previous experience in drug substance/drug product manufacturing, Quality Control and/or Quality Assurance is required.
cGMP auditing experience is required. Certified Quality Auditor (CQA) designation is beneficial.
General knowledge of regulatory requirements for the pharmaceutical/ biotechnology industry is required.
The individual must have excellent communication skills, both verbal and written, and have the ability to work independently and in a team environment.
The individual must have excellent typing skills and be proficient in the use of Microsoft Word, Excel and PowerPoint applications.
Domestic and international travel expected for this position is ~50%.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact admin admin.
