QC Compliance Specialist

Job title:

QC Compliance Specialist

Company:

CareerWise Recruitment

Job description

Job DescriptionA QC Compliance Specialist is by CareerWise Recruitment for our Waterford based pharmaceutical client. This is a 12-month contract position. You would be responsible for the introduce of new QC Laboratory Equipment.Role of this position

• 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 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.

JOB 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).
• Excellent communication skills (interpersonal, presentation & writing)
• 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.ieCareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Expected salary

Location

Waterford

Job date

Sun, 30 Mar 2025 01:40:40 GMT

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