Production - Sterile - Trainee
Job Description
Production Sterile: QMS – Trainee
Deviation Logging: Learn and assist in the initial documentation, registration, and tracking of shop-floor incidents and deviations in the sterile area.
CAPA Follow-Up: Support senior officers in tracking the implementation timelines and closure status of Corrective and Preventive Actions (CAPA).
Document Management: Assist in the systematic tracking, printing, routing, and archiving of Quality Management System (QMS) documents, including Change Controls and logbooks.
SOP Coordination: Learn to draft and format revisions for Standard Operating Procedures (SOPs) and manufacturing checklists under direct technical supervision.
BMR/BPR Review Support: Assist in gathering batch records and data sheets for technical review, learning to identify data integrity gaps according to ALCOA+ principles.
EM Trend Tracking: Help compile, enter, and track Environmental Monitoring (EM) data, particle counts, and differential pressure logs for Grade A/B/C/D cleanrooms.
Audit Preparation: Maintain neat, organized department files and document archives to support continuous audit readiness (USFDA/MHRA).
Compliance Learning: Attend training on cGMP guidelines, sterile manufacturing regulations (such as EU Annex 1), and basic Quality Risk Management (QRM) tools.