Job Description

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 and perform activities for process compliance and product release, when required.

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 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 and Compliance

• Monitor implementation and correct compliance with legislation, policies and procedures

Skills Required

Background/experience

• Minimum of Bachelorxe2x80x99s degree (B Pharm)
• Minimum 4-6 yearsxe2x80x99 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

Aspen Pharmacare