A Quality Control Compliance Specialist is needed by CareerWise Recruitment for our Waterford based pharmaceutical client. This is a 12-month contract position. You would be responsible for the introduction of new QC Laboratory Equipment.
THE ROLE:
* Responsible for the generation of documentation – URS writing, GxP assessments, SOP’s/WI’s.
* Responsible for the review and approval of documentation IOQ, PQ, SOP etc.
* Responsible for upgrade and introduction of instruments in the QC laboratory, to ensure equipment is implemented on time to support product testing in meeting manufacturing & supply deliverables. The analytical instruments include (but are not limited to) UPLC, HPLC, Biacore, CE, Microscope, Balance, O2 Headspace, Karl Fischer, TOC and Plate readers.
* Participate in Change Control Request facilitation and management in relation to QC instrument’s introduction.
* Overall responsible for the introduction of instruments for the QC laboratory.
* Work closely with the Project Manager to ensure adherence to project timelines and critical milestones are met during new instruments introduction.
* Work closely with Validation, QA, IT, Metrology, QC Analyst, SME, and DI team for qualification & validation strategy alignment, timely completion of the GxP assessment, User Requirement Specification, IOQ protocol pre-approvals, and associated documentation.
REQUIREMENTS:
* Education: Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.
* One/two years’ experience in a similar compliance or projects role (preferable).
* Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment.
* Initiative – able to work in a self-directed manner to see issues through to completion.
Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Manufacturing, Science, and Engineering
Industries
Pharmaceutical Manufacturing, Manufacturing, and Research Services
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