Pharmacy Assistant at Aspen Pharma Group South Africa

 Pharmacy Assistant(Contract position) 






Overview
Monitor and report on manufacturing compliance to GMP and statutory requirements
Ensure adherence to guidelines, procedures, document controls and support with related administrative task

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

Skills Required
Background/experience
  • Post Basic Registration with the Pharmacy Council
  • 1-3 years’ related experience in manufacturing
  • Pharmaceutical manufacturing and/ or Pharmacist Assistant experience

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
  • Competencies
  • Interrogating information
  • Meeting deadline
  • Finalising outputs
  • Maintaining accuracy
Accountability and Decision Rights
  • Timely and accurate performance of responsibilities for a single technical area or group of closely related tasks, under supervision
  • Learn and implement policies, procedures, quality and compliance standards
  • Recognise and resolve basic, routine or common/ repetitive problems
  • Seek assistance on complex issues and referring non-prescribed matters
  • Stay up to date on legislation and industry regulations

Decisions relating to;
  • Own work, within limited, defined parameters
  • Prioritisation of basic tasks, with clear guidance

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