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QC Analyst 4740

  • Job reference: 933028
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 03/12/2020

Responsibilities
This position is responsible for carrying out tasks and projects related to
equipment, lab utilities and testing procedures as required by Good
Manufacturing Practice (GMP). Partners with other Departments to ensure
that all QC testing activities are completed in an efficient manner.

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


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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