After Market Pharmacist at Aspen Pharma Group

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

Requirements

 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