Qc Associate - Wrexham, United Kingdom - IPSEN
Description
Title:
QC Associate
Company:
Ipsen Biopharm Ltd
We are currently recruiting for a
QC Associate to join our Analytics Team. This position is a permanent role and based at our
Wrexham, North Wales manufacturing site reports directly to the QC Process Leader - QC Analytics.
The successful applicant will have strong experience in technical competency and knowledge of laboratory testing, to be able to support investigations and contribute to solution finding; demonstrating sound understanding of pharmacopoeia requirements.
Ability to work without close supervision; be able to represent the department in cross functional teams and as a project team member.
Maintain compliance to laboratory procedures, lead by example and work accurately within expected timelines to attain 'right first time'.
Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care with sales growth of 21.1%.
Ipsen aim to make a sustainable difference by significantly improving patients' health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases.
Main Duties & Responsibilities
The QC Associate will include:
_ Analytical sampling and testing:
_
- Perform Analytical testing of drug products and for the purposes of batch release and stability assessment
- Perform sampling of drug products for the purposes of batch release and stability testing.
- Perform and report analysis of customer complaint samples, raw material samples, utility samples and nonroutine samples
_ Maintenance of Equipment and laboratory:_
- Maintain laboratory equipment in accordance with company policies
- Perform Regular stock checks on all samples and reagents within the control of the QC Analytical department
_ Co-ordination and training:_
- Initiate and perform training of test methods as required
- Support laboratory equipment projects e.g. procurement, installation, validation and decommissioning
_ Continuous Improvement:
_
- Be proficient in reviewing lab methods against current pharmacopoeia and licence requirements to ensure ongoing compliance
- Perform internal inspections within the QC Analytical Department to ensure ongoing compliance and implement improvements.
_ Works within GMP/ EHS requirements: _
- To perform assigned tasks whilst always adhering to current GMP requirements.
- Report any compliance concerns to your linemanager or Quality Assurance Compliance.
Skills, Experience & Education:
In return, you will bring:
- Degree or equivalent in Chemistry or Biochemistry, minimum HND or relevant experience
- Experience within a laboratory or cGMP production environment
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