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

Accountability & Decision Rights

• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem-solving skills to optimise team  performance
• Integrate resources for an area
• Escalate highly complex problems or out-of-policy issues

Independent decisions relating to:

• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training and/ or education
• Establishing own work priorities and timelines
• Interpretation of policies, standards, requirements and approaches

Closing Date: 4th,July 2022