QC Senior Analyst (FTC)応募 後で応募 求人ID R0010453 掲載日 07/12/2019 Location:Dublin, Ireland
The QC Senior Analyst has an important role to play in Quality Control laboratory and the routine operation of the QC laboratory in TIL GC. The QC Senior Analyst will have specific and varying duties. Some key tasks and responsibilities are outlined below. Flexibility is an important attribute to have as responsibilities may change as other duties may arise. Availability to work different shift patterns (for example; 16/5, 24/5 and 24/7) is a requirement.
- Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7A.
- 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
Analytical Scheduling / Review:
- 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 and finished API 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.
- Lead method transfer and method validation projects as required.
- Review equipment qualification documentation for QC Laboratory equipment.
- Participate in the cleaning validation programme at the TILGC facility.
Good Laboratory Practices:
- 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.
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- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL 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.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- Minimum of a BSc Degree (life science)
- A minimum of 6 years’ work experience in a regulated GMP/GLP environment
- Experience of leading other QC analysts in scheduling daily activities, minimum 1 year
- 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 in an API facility, desirable but not essential
- Experience working on cross functional teams
- Good time management
- Experienced in technical writing
- Ability to lead others and demonstrate Leadership skills
Grange Castle, Ireland
Fixed Term (Fixed Term)