Cache of job #13961420

Job Title

QC Chemist - QC Technical Support

Employer

Pe Global

Location

Cork

Description

PE Global are currently recruiting for a QC Chemist for one of our pharmaceutical clients in Cork. It is a permanent role with a competitive salary. The role will be supporting the QC Technical Support Group. Key strengths in the area of analytical testing to support: Analytical method transfers & validations. Process and cleaning validations for New Product Introduction. Ad-hoc technical investigations. Commercial release as required. Responsibilities: Generation, review and approval of validation lifecycle documentation including change controls, risk assessments, protocols, reports etc. AMT: Method Validation Gap Assessments, Pre Transfer Training, Method Transfer/Validation, Transfer to Commercial. Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols. Empower/LIMS Processing. Leads and coordinates reviews and investigations for out- of trends/out –of specifications. Troubleshoots instrumentation/test methods and associated corrective maintenance as required. Represent QC and participate in cross functional teams. Provision of analytical testing status updates at governance forums. Escalation of risks and implements appropriate mitigations. Timely completion of Change Controls, CAPAs, Tasks etc. Assists in the training of QC staff as needed. Conducts GMP reviews of logbooks. Implements LEAN and 5S initiatives as required. Data review to ensure compliance to appropriate specifications and protocols. Knowledge, Experience and Skills: Working knowledge of GMPs, pharmacopoeia, and regulatory requirements for analytical testing. Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs. Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC – a distinct advantage. Proficient in LIMS & Empower etc. Troubleshooting and problem solving skills to support root cause analysis. Organizational skills. Strong verbal, technical writing and interpersonal communication skills are required. Proficiency in Microsoft Office. 5 years + of relevant experience and a BS degree in Chemistry or equivalent. Relevant experience in a pharmaceutical operations environment. If you are interested in this position, please forward your CV to tina.dorgan@peglobal.net or call 0214297900 . Alternatively please feel free to connect with me on LinkedIn. 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

1963 days ago

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