- The QC Senior Analyst will work in the Quality Control Laboratory in our company.
- The QC Senior Analyst has an important role to play in the start-up of and the routine operation of the P2 QC laboratory.
- The QC Senior Analyst will have specific and varying duties.
- Some key tasks and responsibilities are outlined below.
- Flexibility is an important attribute as responsibilities may change as other duties may arise.
- Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7.
- 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.
- Participate, as directed, in the following activities in the QC laboratory:
- Equipment Calibration
- Equipment Maintenance
- Laboratory Auditing
- LIMS data management and maintenance
- Lead method transfer and method validation projects as required.
- Prepare and review equipment qualification documentation for QC Laboratory equipment, including data integrity requirements.
- Participate in the cleaning validation programme at the TILGC facility, including development of analytical methods as required.
- Provide expertise in a variety of analytical test procedures.
- Review all analytical data in a timely manner with a high attention to detail.
- Plan and prioritise scheduling tasks for other analysts within the QC laboratory.
- Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, API and finished drug product according to approved TIL GC procedures and plant schedules, when required.
- Ensure that all testing information is recorded accurately and completely according to TIL 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.
- Provide guidance in deviation investigations, OOS investigations, change proposals and batch disposition.
- Lead investigations where necessary.
- Provide samples to contract testing laboratories and liaise with these laboratories as required.
- Ensure analysts are adequately trained as per TILGC SOP’s.
- Ensure good Data Integrity practices are maintained and followed at all times.
- Ensure that Good Laboratory Practices are followed at all times.
- As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.
Minimum of a BSc Degree (life science)
- A minimum of 5 years’ work experience in a regulated GMP/GLP environment
- Experience of leading other QC analysts and scheduling daily activities
- Experience troubleshooting QC methods
- Practical experience with wet chemistry methods
- Experience with writing and reviewing SOP’s / validation protocols / reports
- Experience with Method transfer / validation is essential
- Experience working on cross functional teams
- Excellent organisational, communication, interpersonal and report writing skills
- Demonstrable experience motivating and leading a team of Analysts
- Ability to adapt to changing priorities