Cache of job #13963229

Job Title

Supplier Quality Auditor

Employer

Pe Global

Location

Cork

Description

Our client in Cork is currently looking for a Supplier Quality Auditor for a permanent role. This role will be responsible for assisting the Auditor Manager in ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. This role will require ongoing travel to Asia. The Role: Lead and conduct quality inspections of outsourced manufacturing facilities, Lead and conduct responsible sourcing inspections of outsourced manufacturing facilities as per company guidelines. Lead and conduct quality inspections of other third-party service providers such as packaging sites, API manufacturing facilities and contract laboratories. Compile inspection reports to include findings, corrections and process improvements. Track corrective actions and planned action agreements from inspections to closure. Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS. Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary. Keep the Management team and colleagues updated on issues and actions which impact the business. Participate in regular team and group meetings. Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required. Requirements. At least 6years previous experience in a high volume manufacturing environment. Degree in Engineering/Quality/Science. Proven external/internal auditing experience. Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and CFR part 210 / 211 regulations, 21 CFR Part 11 regulations. Solid understanding of Quality Management Systems. Ability to compile and made presentations at external sites to senior management level. Ability to work independently and make decisions based on judgement and integrity. Ability to work effectively independently and with others to accomplish goals in a challenging environment. Excellent organisational and time management skills. If you are interested in this role please email CV to aoife.lomasney@peglobal.net or contact Aoife Lomasney on 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

Date Added

1959 days ago

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