QC Chemist.
Location: Waterford
Our client is a leading biologics company who has continued to grow and diversify to serve patients around the world. Their site in Waterford comprises of almost 800 employees who work together at a state of the art biopharmaceutical and medical device campus. Our client is looking for a QC Chemist to join their team as a contractor.
You will contribute to the continued success of their QC department by providing analytical services to support their diverse manufacturing operations .Engage with their Continuous Improvement programme to share your ideas and experience to further optimise their laboratory function.
Main responsibilities:
- Provide analytical chemistry services and support to Site.
- Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
- Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory requirements.
- Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
- Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
- Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
- Ensure all quality documentation and records are complete and current.
- Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
- Ensure relevant procedures are correctly defined and followed.
- Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
- Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
- Checking/auditing laboratory notebooks and analytical reports.
- Ensure compliance to cGMP at all times.
Skills and Experience Required:
- Degree in Science (Chemistry or Biochemistry preferred). Post-graduate studies as appropriate to augment primary degree.
- 2-3 years experience working in a manufacturing environment preferred.
- Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability.
- Understand relevant quality/compliance regulations.
If you feel that this role would be of interest to you please reach out to Louise at [email protected]
* Please note only applicants with valid right to work status in Ireland at time of application will be considered for the role
We look forward to receiving your application!