After Market Pharmacist Assistant
1 day ago
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
Skills required **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 **Accountability & Decision Rights** - Correction and/ or containment of errors of significant impact (financial loss, customer business, materials and/ or equipment downtime)
- Prioritisation of tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks
Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos
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