QC Compliance Specialist

Hobson Prior is seeking a QC Compliance Specialist for a 6 month contract position based in Galway. This role will focus on quality control and compliance within a pharmaceutical environment. The successful candidate will be responsible for writing and revising standard operating procedures, handling quality events, and maintaining laboratory documentation to GLP standard.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Write and revise standard operating procedures (SOPs), Finished Product Procedures, Raw Material Testing Procedures, and other QC associated GMP documents.
• Display competency in technical areas such as Chromatography (HPLC, GC, UPLC), Spectroscopy (IR, UV), dissolution & physical testing.
• Adhere to existing methods with reference to pharmacopoeia's, specifications, regulations, and industry standards.
• Prepare analytical method transfer, method validation protocol and report.
• Prepare and review Lab incident reports, Out of Specification, Out of Trend, Out of Expectation results.
• Handle quality events (Deviations, CAPA, Change Control) effectively to its closure.
• Review calibration and maintenance of laboratory equipment as per calibration procedures.
• Maintain all laboratory logbooks, notebooks & associated documentation to GLP standard.

Requirements

• 3rd level qualification - Bachelor's degree in a science-based discipline.
• Strong computer skills in MS Office.
• Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.
• Competency in areas such as SOP, FPP, CCF, Deviation, CAPA, Chromatography, Spectroscopy, dissolution & physical testing.
• Ability to build relationships and collaborate with others.
• Good communication skills, both verbal & written.
• Maintains the highest standards of ethical behaviour.
• Escalates issues appropriately.
• Flexible and shows willingness to learn to develop technical skills.
• Takes a methodical, systematic, and structured approach to organising work.
• Positive and proactive person who is energized by having great responsibility.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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