Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent?
Senior QC Laboratory Analyst
Part time hours; 22.5 hours per week (3 shifts per week)
Shift position: Week 1 – Morning shifts & week 2 – Late shifts (Rotating)
Morning shift: 06.00 – 14.00
Late shift 13.30-22.00 (Mon-Thu) and 1:30pm-7pm (Fri)
Catalent Pharma Solution require a Senior QC Laboratory Analyst to join our Dartford team. This facility specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry.
The role: Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation (including particle size and cleanability assessments), DSC, Light microscopy, SEM, Moisture content (Karl Fisher), method optimisation and troubleshooting, technology transfer and pharmacopoeia analyses as appropriate Drive implementation and maintenance of the 5S methodology in QC Support the management of QC metrics Act as a trainer to new members of the QC team, including providing explanation on the basic principles of operation with regards to analysis being performed. Keep up to date with industry/regulatory developments in relation to particle size technology To have a good understanding of PSA / HPLC/ DSC analytical equipment and methods Prepare and review Standard Operating Procedures (SOP’s), including corporate and departmental guidelines. Prepare, review and execute analytical test reports for submissions to clients or other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates, Method Qualification/ Validation Protocols, Method Qualification/Validation Reports and Laboratory Technical Transfer Studies. Experience of GMP requirement with regard to laboratory activities including deviation, change control and laboratory investigation. Ensure compliance with data integrity requirements of laboratory equipment and software systems.
The candidate: Science graduate or higher with proven experience of laboratory operation in a cGXP environment or extensive industry experience. Particle Size experience desirable 5 year’s experience in HPLC: Empower, Trouble shooting of equipment, Method Development and Validation Experience in QC Lab: Investigations, CAPA’s, Deviations, Writing SOP’s Ability to mentor and train junior staff