Scope of Work:
A) Performs routine and non-routine testings in the following areas with good observation of ALCOA+, cGMP, cGDP and cGLP requirements:
- Chemical testings for raw materials and utilities samples
- Chemical testings to support manufacturing processes, process validations, cleaning validations and reagent qualifications
- Timely support for projects and new product introduction (NPI) such as method verification and method validation / transfer (when required)
- Ensures right-first-time test executions and documentation, with schedule adherence.
- Performs peer review for verification of task and data.
B) Ensures training competencies are up-to-date and comply to global GSK training policies.
C) Performs equipment troubleshooting, calibrations, maintenance and verifications as assigned. Initiates repair work requests and liaise with vendors as necessary.
D) Identifies and reports issues (e.g. invalid results/OOS/atypical results/equipment failure) in QC to superintendent/manager in a timely manner. Participates in laboratory investigations (when required) and assist in timely closure of investigations and CAPAs.
E) Assists in document drafting and periodic review (e.g. SOPs, OJTs, WRAs, CRAs, QMCs, control charts)
F) Supports activities related to GPS (e.g. tiers, Gemba, DMAIC, 5S, standard work etc) for continuous improvement. Practises 5S and ensures good housekeeping of laboratory, work area and equipment. Also support lean activities and improvement projects with achievements.
G) Takes initiative to ensure good inventory of QC materials and reagents (e.g. purchased chemicals and prepared materials / glassware) to support testing activities; ensures no overstocking of inventory
H) Ensures inspection-readiness of the QC laboratories.
I) Adheres to all safety and security policies and practices. Ensures wastes are disposed appropriately and promptly.
J) Adhoc weekend, off-office hours support.
Timeline: 1 year contract
