After Market PMA at Aspen Pharma Group

Overview

• Compilation of APQRs and PQRs  
• Handling of complaints and recalls processes

Responsibilities

Process improvement and support

• Carry out internal audit activities
• Provide support during external GMP audits by regulatory and other bodies
• Maintain SOPs

APQRs and PQRs

• Compile APQRs and PQRs
• Conduct and maintain accurate records of product reviews, as required by health authorities
• Communicate APQR and PQR requirements, recommendations and processes with relevant departments

Complaint resolution

• Handle customer complaints, queries and adverse drug reactions and related investigations
• Conduct complaint intake, triage and investigation  
• Assist in the handling of returns and recalls, as required

Reporting and analysis

• Conduct preliminary trend analyses and report
• Conduct preliminary root cause analysis and risk assessments and report
• Consolidate information for reports specific to area of responsibility

Planning and procedures

• Plan for and prioritise own tasks and responsibilities, within standards and procedures, to fulfil work requirements
• Determine resource needs of own area of work
•  Optimise current processes

Requirements
Background/experience

• 2 to 4 years’ related work experience
• Learnership and registered PMA

Specific job skills

• Report writing skills
• Working knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
• Understanding of the pharmaceutical manufacturing and corrective action programs, pharmaceutical standards and compliance requirements

Competencies

• Customer Awareness  
• Following Procedures Interrogating Information
•  Organisational Citizenship