Contract Production Pharmacist Assistant
Aspen Pharma Group
East London, Eastern Cape
Part-time
Monitor and report on manufacturing compliance to GMP and statutory requirements. Monitor adherence to guidelines, procedures, document controls and related support and administrative tasks.
Background/experience
? Post Basic registration as Pharmacist Assistant with Pharmacy Council
? 1-3 years’ Pharmacist Assistant experience
? Relevant pharmaceutical manufacturing experience advantageous
Specific job skills
? Basic technical knowledge of pharmaceutical manufacturing, standards and compliance requirements
? Ability to interpret and implement policies, processes and objectives
Competencies
? Interrogating information
? Meeting deadline
? Finalising outputs
? Maintaining accuracy
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
Reporting lines / interfaces
? Reporting to: Production Team Leader
? Supporting structures: QC, QA
Deliverables
? Production activities comply with standards and statutory requirements
? All verifications and inspections are completed
? Change controls comply with SOPs, standards and specifications
? Customer complaints are dealt with and resolved timeously
? All compliance and audit checks are completed
? Deviations are raised, risks assessed and corrective plans implemented
? Maintenance issues are reported
? New staff trained and current staff training needs identified
Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
Closing Date: 1 April 2022
Apply Here: https://aspen.mcidirecthire.com/SouthAfrica/External/Application
Aspen Pharma Group