Job Description
My client a leading Pharmaceutical company now requires a Senior QC Analyst to join their expanding team.
The Senior QC Analyst has an important role to play in the start-up of the Quality Control laboratory in a new biologics manufacturing facility and the routine operation of the QC laboratory when start-up is complete.
This is a permanent role based in Dublin with an excellent salary and benefits.
Responsibilities of Senior QC Analyst
Contribute effectively to the design and implementation of quality systems in the QC laboratory
Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
Equipment Calibration and Maintenance
Purchasing, Laboratory Auditing
LIMS data management and maintenance.
Schedule other analysts work and review of other analysts documentation and test results
Stand in for QC Executive when required
Carry out sampling and analytical testing of raw/starting materials, Master Cell Stock, Drug Substance and Drug Products according to approved company procedures and plant schedules.
Ensure that all testing information is recorded accurately and completely according to company procedures.
Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Executive so that corrective action may be taken.
Lead root cause analysis in deviation investigations, OOS investigations, and change proposals. Determine CAPAs required preventing reoccurrences.
Provide samples to contract testing laboratories and liaise with these laboratories as required.
Training of analysts
Review of method transfer and method validation protocols and reports.
Carry out method transfer and method validation work as required, to meet project deadlines.
Review equipment qualification documentation for QC Laboratory equipment.
As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Prepare for and support internal and external audits (FDA, HPRA, corporate).
Prepare and review documents as required
Requirements of Senior QC Analyst
A minimum of 4 years' work experience in a regulated GMP/GLP environment
Minimum of a BSc Degree (life science)
Practical experience with HPLC systems and troubleshooting
Practical experience in cell counting, morphology and flow cytometry is desirable.
Experience with writing and reviewing SOP's / validation protocols
Experience with Method transfer / validation
Experience working in an Biologics facility, desirable but not essential