Production Sterile - QMS - Sr. Officer
Job Description
Production Sterile: QMS – Senior Officer
Investigation & Root Cause Analysis: Lead thorough technical investigations for sterile shop-floor deviations, environmental monitoring (EM) out-of-specification (OOS/OOL) trends, and media fill failures using tools like Fishbone and 5-Why analysis.
CAPA & Change Control Management: Draft, implement, and track complex Corrective and Preventive Actions (CAPAs) and Change Controls to ensure sterile manufacturing updates comply with global regulatory guidelines.
EU Annex 1 & Regulatory Compliance: Ensure all sterile production practices, cleanroom behaviors, and documentation framework align perfectly with current EU Annex 1, USFDA, and MHRA regulations.
Contamination Control Strategy (CCS): Assist in updating and maintaining the facility's CCS by assessing risks related to personnel movement, material transfer, disinfection protocols, and HVAC performance.
BMR/BPR Technical Review: Perform critical, high-level reviews of completed Batch Manufacturing and Packing Records for sterile batches to verify ALCOA+ data integrity compliance before QA release.
Risk Assessments: Author and execute Quality Risk Assessments (QRM/FMEA) for process modifications, equipment interventions, or cleanroom smoke study observations.
Audit Readiness & Representation: Maintain the sterile department in a permanent state of inspection compliance and act as a technical subject matter expert (SME) during regulatory audits.
SOP Authoring & Training: Write, revise, and roll out complex technical Standard Operating Procedures (SOPs) and execute targeted cGMP training for sterile area personnel.