Qc Associate (Senior)

Overview

Global Biotechnology company, based in south Dublin, Ireland – looking for

QC Associate (Senior)

The successful candidates responsible for one or more of the following activities in QC include analytical testing of EU release, commercial, stability, utilities, raw materials and validation.

Responsibilities

Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.

Deepens technical knowledge through exposure & continuous learning.

Knowledge of related regulatory / industry considerations, compliance issues and / or scientific discovery.

Plan and perform analyses with great efficiency and accuracy.

Plan and perform multiple, complex routine / non-routine methods and procedures and a large variety of assays.

Report, evaluate, back-up / archive, trend and approve analytical data.

Troubleshoot, solve problems, and communicate with stakeholders.

Initiate and / or implement changes in controlled documents.

Participate in audits, initiatives and projects that may be departmental or organizational in scope.

Review protocols and perform assay validation and equipment qualification / verifications when required.

Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.

Qualifications

Bachelor's degree in a Science related field is required.

4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Demonstrated ability to work independently and deliver right first-time results.

Works under minimal directions are guided by objectives of the department or assignment.

Refers to technical standards, principles, theories and precedents as needed.

May set project timeframes and priorities based on project objectives and ongoing assignments.

Recognizes and escalates problems.

Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to

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