QA Team Leader: Aspen

QA Team Leader

Reference Number: QATL – LN

Overview

• Interpret and implement quality procedures, standards and specifications for value streams
• Manage and coordinate value stream QA activities
• Coordinate and execute the review and approval of in-process quality programs
• Manage and coordinate admin functions within quality systems
• Performance management of direct reports
• Perform activities for process compliance and product release, when required

Responsibilities

Planning & 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 and allocate assets and resources for the fulfilment of work objectives and monitor their use
• Provide section staff with day-to-day direction and tasks
• Run effective performance review meetings
• Attend L1-2 meetings
• Ensure visual performance boards are updated
• Completion and monitoring of time and attendance

Product Release

• Verify batch release conditions and documentation
• Manage and coordinate process to determine disposition of products
• Manage and coordinate batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
• Perform batch release when required

Process Compliance

• Issue, track and approve CAPA requests
• Manage implementation of operational changes to SOPs and processes
• Manage and coordinate process compliance activities to ensure that batch release is consistent with OTIF and planning schedule
• Leading deviations related to country requirements

In Process Quality Management

• Manage and coordinate in-process internal inspections
• Governance, Risk & Compliance
• Monitor implementation and correct compliance with legislation, policies and procedures

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
• Planning and Organising
• Finalising Outputs

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