QC Analyst

  • Cork
  • Contract 12months
  • JO-1812-64051_1543938565


General Responsibilities

* 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.

Qualifications and experience

* 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

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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