After-market Pharmacist

2 weeks ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**
- Implement after-market compliance systems and quality procedures, standards and specifications
- Identify and provide solutions to systematic issues
- Create and review APQRs and PQRs
- Deal with complaints, recalls and CAPAs

**Responsibilities**

**Process improvement and support**
- Initiate, coordinate, perform and follow up on internal audits
- Provide support during external GMP audits by regulatory and other bodies and perform audit follow-up
- Review validation protocols and reports
- Review GMP-relevant technical/ engineering documentation
- Review and approve event handling and change control
- Compile and maintain SOPs
- Review and sign off change requests and validation documents

**APQRs and PQRs**
- Perform APQR and PQR processes/ systems
- Review compiled APQRs and PQRs
- Compile APQRs and PQRs if necessary
- Provide input into product reviews as required by health authorities
- Engage with relevant departments to address recommendations and outstanding information

**Complaint resolution**
- Handle customer complaints, queries and adverse drug reactions and related investigations
- Conduct complaint intake, triage and investigation
- Handle returns and recalls, as required
- Interact with health authorities, where required

**Correction and prevention**
- Initiate CAPAs and follow up with relevant departments related to Events, Audits, Self-inspections, Complaints and PQRs
- Review and approve event handling and change control

**Reporting and analysis**
- Categorise complaints, conduct trend analyses and report
- Conduct root cause analysis and risk assessment and report

**Planning and operational support**
- Provide technical and operational input during drafting of plans and procedures specific to unit
- Request, allocate and monitor the use of assets and resources for the fulfilment of work objectives
- Stay up to date on developments, trends, legislation and regulations
- Provide information for reports, as required by superior

**Skills required**

**Background/experience**
- Bachelor’s degree (B Pharm) with 4-6 years’ related work experience, or Post Graduate Degree/ Diploma with 2-4 years’ related work experience
- Pharmaceutical manufacturing experience

**Specific job skills**
- Protocol and technical report writing skills
- Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
- Advanced understanding of the pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Information Gathering
- Interrogating Information
- Managing Performance
- Offering Insights
- Endorsing Quality Standards

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