Senior Quality Assurance Engineer Biotech

Description

Sr. Associate Quality Assurance

My client is a leading global Biotech company and they are currently seeking an experienced Senior Quality Assurance Associate. The Snr QA Associate will be a core member of the site Quality Assurance team supporting manufacturing operations and will serve as Quality point of contact for manufacturing. The site is focused on continuous improvement of all work processes and practices. It offers a busy and exciting work environment in a company that are expanding.

Functions:
* Quality representative in Non Conformance triage and Root Cause Analysis
* Review and approval of Non Conformances and CAPAs.
* Write, review and approve Standard Operating Procedures

Policies:
* Perform AQLs.
* Observation and assessment of interventions on aseptic fill line
* Perform quality walks of manufacturing area and manage actions
* Performs Quality Audits to ensure compliance with cGMPs
* Approves Systems validation protocols on behalf of QA.
* Review and approve Master Batch Records
* Review and approved Work Orders
* Review of electronic and / or paper BR's
* Compile QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. Perform status changes, yields and assign expiry date to products. Prepare deviation reports for shipments as required
* Manage site quality management review meetings.

Requirements
* Bachelors Degree in Science or Engineering related discipline
* Minimum of 3 years of directly related QA / Aseptic manufacturing experience.
* Excellent knowledge / experience in aseptic manufacturing
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
* Strong word processing, presentation, database and spreadsheet application skills
* Strong communication (both written and oral), facilitation and presentation skills
* Ability to evaluate compliance issues

This is a permanent role with an excellent salary, shift allowance and very attractive benefits package. Please note that shift work is required as part of this role. This role is based in South Dublin and is extremely urgent- interviews and feedback will be soon so if you are interested please apply now for immediate consideration and call me Adele Moran on for more information.

To find out more about Real please visit www.realstaffing.com