QS Team Leader at Aspen Pharma Group

Overview

Coordinate QS activities, including:

• Quality Risk Management (QRM), root cause analysis, change control and product failures
• Recording and trending of data
• Documentation systems and controls
• Interpret and implement quality procedures, standards and specifications
• Coordination and management of APQR, PQR and customer complaints
• Coordination and management of regulatory audits

Responsibilities

Planning and section management

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
• Provide input into budget and resource requirements of section
• Request, allocate and monitor use of assets and resources
• Provide section staff with day-to-day direction and tasks
• Run effective performance review meetings
• Ensure visual performance boards are updated
• Complete and monitor time and attendance

Policy, procedure and document management

• Provide input into and implement quality manuals and policies
• Draft and maintain SOPs and process docs; review output documents
• Maintain compliance with recordkeeping regulations
• Implement QRM and continual improvement systems/ programmes
• Participate in investigations into process and quality problems and preventative planning

QS implementation

• Coordinate APQR and PQR processes
• Oversee generation, investigation, documentation, implementation, verification, closure, effectiveness and trending of CAPAs
• Coordinate and monitor complaints handling and investigations processes, including complaint intake, triage and investigation, handling of returns and recalls, and interacting with health authorities

Process compliance

• Manage the implementation of changes to SOPs and processes
• Monitor implementation and correct compliance with legislation, policies and procedures
• Oversee QS involvement in external (regulatory) audits

Review and reporting

• Manage and oversee data integrity activities
• Coordinate data collection, trending and analysis of KPI’s and tracking and reporting on quality metrics
• Prepare draft reports

Requirements
Job Requirements

• Background/experience
• Minimum of Bachelor’s degree (B Pharm)
• Minimum 4-6 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Strong working knowledge of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• People management
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogating Information
• Managing Performance
• Offering Insights
• Taking Action
• Setting Standards