QA Team Leader - Port Elizabeth at Aspen Pharma Group

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
• 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 prioritization 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 Organizing
• Finalizing Outputs

Accountability & Decision Rights

• Set overall direction for team in alignment with unit policies, objectives and OTIF and planning schedules.
• Manage budget(s) for teams and/ or small projects.
• Exercise interpersonal, communication, training and problem-solving skills to optimize team performance.
• Escalate highly complex problems or out-of-policy issues.
• Provide support to production operations to ensure quality at source, providing the necessary quality references and policies and executes problem solving and risk-based approaches to operational activities.

Independent decisions relating to:

• Resources, approach, and tactical operations
• Staff productivity and operational processes, tools and services
• Establishing own and teamwork priorities and timelines
• Interpretation of policies, standards, requirements, and approaches

Deliverables

• In-process control programs effectively implemented, controlled, and monitored in production value streams
• Batch release requirements are met and verified in line with OTIF and planning schedule
• Disposition of products determined correctly
• Operational changes to SOPs and processes implemented in compliance with control process
• Retention samples stored according to SOP
• Quality systems maintained and updated
• Documentation stored/ archived according to SOP
• Develop priorities and KPIs for section.