Sterile Support SME (Port Elizabeth) at Aspen Medical

Description
Overview

Coordinate personnel CRR monitoring, including:

• Capturing, recording, trending and reporting of personnel CRR%
• Non batch related personnel MDD investigations as well as CRR excursions’ counselling and training
• Internal and external regulatory audits related to CRR excursions
• Monitoring Clean Room Behaviour of sterile core staff

Responsibilities :

• CRR program maintenance and monitoring
• Coordinate and review CRR data collection / capturing, analysis, tracking of CRR data. 
• Statistical breakdown of personnel sampling, MDDs and trends, Calculation of mean CRR.
• Evaluate and coordinate compliance reviews of all clean room personnel behaviour,  improvement actions to address CRR transgressions and personnel CRR trends.
• Evaluate and provide input to training modules to align and address latest trends identified.
• Capture and track Cleanroom access, media fill participation,  CRR refresher status, gowning qualification status and intervention participation status.
• Advise on mediafill role allocations and commercial batch participation based on CRR status.  
• Evaluate and action non batch related personnel MDDs.
• Publish CRR % status report and publish status on performance boards
• Optimise current CRR process

CRR and MDD Counselling / Training / Investigations

• Provide input into and address Clean Room staff concerns and suggestions and implement preventative / corrective actions and continual improvement in response to personnel CRR excursions and MDDs
• Perform counselling / training with clean room staff involved at intervals prescribed by SOP.
• Discuss MDD contaminants and sources with MDD staff
• SOP and standard form training related to personnel MDD and CRR
• Monitoring Clean Room Behaviour of Sterile Core Staff
• Video Footage review of MDD investigations, Gowning Assessments, Clean Room behaviour, Cleaning and EM sampling and give feedback to staff.
• Coach cleanroom staff regarding aseptic technique, behaviour and cleaning practices and techniques.
• Other related support functions
• Internal / External quality audits of departments or external vendors that impact on personnel CRR% and or / MDDs
• Provide support during external GMP audits by regulatory and other bodies
• Initiate and complete SOP and standard form updates, CAPAs and Change Controls required to implement personnel system
• Assist QS with sterile support projects and process compliance

Requirements

Background/experience

• Degree or Diploma in Microbiology, with minimum of 10 years sterile manufacturing experience
• Experience in EM sampling in sterile manufacturing facility 
• Experience in evaluating compliance of Clean Room Behaviour
• Experience in GMP regulated industry in a QA and auditing role

Specific job skills

• Strong working knowledge of clean room behaviour, cleaning technique, aseptic technique, EM sampling technique
• Strong problem solving skills identifying preventative and corrective actions required to reduce MDDs and CRR
• Training and Communication skills
• Understanding of the pharmaceutical manufacturing and corrective action programs, pharmaceutical standards and compliance requirements

Competencies

• Implementing re-launched CRR system
• Offering Insights
• Taking Action
• Investigative skills
• Interrogating Information
• Information and data gathering