Overview

§   Monitor manufacturing compliance to GMP and statutory requirements
§   Monitor adherence to guidelines, procedures, and document controls
§   Related support and administrative tasks
 

Responsibilities

Inspections and Verifications
§   Perform visual inspections of rooms, machine parts and equipment
§   Verify that rooms and equipment are certified clean as per SOP
§   Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
§   Verify daily sampling, dispensing of materials and its mass/ volume
§   Perform housekeeping of rooms and equipment
 
Line & Production processing
▪       Perform line sign-on and closure
▪       Check and authorise packaging line clearance
▪       Order and maintain substance materials
▪       Perform batch reconciliations to product specifications and quality
▪       Monitor production process in line with standards and specifications
 
Process and system improvements
▪       Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
▪       Manage and resolve customer complaints
▪       Optimise processes and identify gaps in policies/ procedures
 
Compliance & Auditing
▪       Conduct shift GMP checks and ensure continued compliance
▪       Conduct environmental checks and check expiry dates of agents
▪       Verify good document practice as per SOP and regulation
▪       Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
▪       Verify IPCs are in line with product quality and specifications
▪       Check preliminary batch records
▪       Audit logbooks and systems
 
Troubleshooting
▪       Investigate deviations and concessions and assess risk
▪       Raise deviations and implement corrective action
▪       Raise maintenance notifications as and when required
 
Training and technical expertise
▪       Train new PMAs on SOPs
▪       Identify refresher or awareness training needs
Administration & Record keeping
§   Complete batch records and labels
§   Complete deviation forms as required
§   Query documents and sign off declarations
§   Perform and verify calculations in BMR
§   Maintain and update records and systems as required