Cache of job #13920096

Job Title

QA Specialist - Athlone

Employer

Pe Global

Location

Athlone, Roscommon

Description

PE Global are currently recruiting for a QA Specialist for a client site in Athlone – Principal Responsibilities The successful candidate will be responsible for: Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to Athlone manufacturing. Acts as quality point person, providing guidance and feedback on quality assurance issues. Ensure relevant QA documents and procedures are approved to schedule to support technologytransfers and new product introductions. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Review and approval of Change control activities to ensure any impact on GMP is appropriately assessed. Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required. Supports review and approval of quality control documentation for the release of materials on site. Provides oversight of contract laboratories, as required. Review and approval of manufacturing batch records to support QP release of drug product in AAMF. Supports inspection readiness activities. Actively contributes to continuous improvement activities. Any other duties as required. Qualifications A minimum of 3 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Excellent accuracy and attention to detail. Good knowledge of relevant computer packages e.g. Trackwise or similar. Technical writing skills required. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. Education Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience. Interested Candidates should send their CV to Audrey.brennan@peglobal.net or call 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

2081 days ago

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