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Scientific & Laboratory

Job Description

An experienced QC Analyst is required on a 12 Month basis by CareerWise Recruitment for our Cork-based multinational pharmaceutical Company. This position is responsible for carrying out tasks and projects related to testing procedures, equipment and lab utilities as required by Good Manufacturing Practice (GMP). The successful Candidate will partner with other Departments to ensure that all QC testing activities are completed in an efficient manner.

Role of this position

  • Achieves a high level of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products
  • Review and approval of laboratory test results
  • Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines
  • Executes validation, operation, maintenance, calibration and troubleshooting of equipment and associated software
  • Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use
  • Ensures that all testing is completed, reviewed and approved within agreed turnaround times
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards
  • Trains other QC analysts in laboratory methods and procedures when required
  • Writes/updates and reviews TMs, SOPs and WIs as required
  • Writes and reviews invalid assays, non-conformances and deviations as required
  • Actively participates in lean initiatives such as Kaizen, 6S and Gemba
  • Communicates relevant issues to the QC Team Leader promptly
  • Maintains and develops knowledge of analytical technology as well as cGMP standards

JOB REQUIREMENTS

SPECIFIC TESTING EXPERIENCE REQUIRED
  • HPLC
  • Capillary Electrophoresis
  • UPLC/Mass Spec (desirable)

KEY COMPETENCIES REQUIRED
  • Good knowledge of LIMS, Trackwise and Electronic documentation systems
  • Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint
  • Experience working in a high throughput laboratory environment

QUALIFICATIONS AND EXPERIENCE
  • BSc (Honours) in a scientific/technical discipline
  • A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry
  • Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise 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.

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Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie