Overview
QS Compliance Pharmacist Assistant Jobs in Port Elizabeth, South Africa at Aspen Pharma Group
Monitor manufacturing compliance to GMP and statutory requirements
Monitor adherence to guidelines, procedures, and document controls
Related support and administrative tasks
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
Complete batch records and labels
Query documents and sign off declarations
Perform and verify calculations in BMR
Maintain and update records and systems as required
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Compliance Assistant
• Port Elizabeth, ZA
#J-18808-Ljbffr
Title: QS Compliance Pharmacist Assistant
Company: Aspen Pharma Group
Location: Port Elizabeth, South Africa
Category: Manufacturing / Production
