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Scientific & Laboratory

Job Description

QC ANALYST, IN PROCESS TEAM on 4 cycle shift required by CareerWise Recruitment for our pharmaceutical client in Cork. Initial 12 month contract, 12 hour shifts (7-7); 2 days, 2 nights, 4 days off. The QC ANALYST, IN PROCESS TEAM is responsible for supporting 3 manufacturing suites, performing QC testing for samples taken at all stages of the manufacturing process for both commercial and clinical biologics.

Role of this position

  • Achieves competency in laboratory methods and procedures.
  • Trains other QC analysts in laboratory methods and procedures when required.
  • 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 its associated software.
  • Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
  • Performs routine and non-routine analytical testing activities.
  • Review and approval (where appropriate) of laboratory test results.
  • Ensures that testing and results approval are completed within agreed turnaround times.
  • Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
  • Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
  • Deals with non-conformances/ deviations in an accurate and timely manner.
  • Deputizes for the QC Team Leader as appropriate.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.
  • In process control testing and activities to support the production Units
  • Liaisons with Operations department regularly throughout the day to ensure testing activities are completed in an efficient manner and issues rectified.

JOB REQUIREMENTS

  • A third level qualification of a scientific/technical discipline is required.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  • Builds strong productive relationships.
  • Demonstrates ability to work with teams and individuals
  • Asserts personal ideas and opinions using persuasion to influence others
  • Seeks opportunities to grow and develop professionally
  • Uses best practices to improve business operations
  • Holds self-accountable for compliant and flawless execution
  • Takes personal responsibility for decisions that successfully build customer value
  • Effectively manages and adapts to change
  • Demonstrates the courage to stand alone on ideas and opinions that differ from others
  • Listens effectively and remains open to other's ideas.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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