Audit Manager
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in City of London United Kingdom.
- 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
- 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.
- 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 Riko Arends.
The Company
Our client is a Pharmaceutical company in the greater London area.Role Description
Audit ManagerResponsibilities
- Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external suppliers/ vendors/ service providers such as contract manufacturing organisations, suppliers of raw materials, laboratory operations, logistics providers, and GMP service providers.- 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 biotech areas.- 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.
- 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 Riko Arends.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
