Production Sterile QMS Sr. 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 facilitys 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.