Validation Manager

October 19, 2024

Port Elizabeth

FULL TIME

Overview

Control and manage validation function to ensure equipment is validated in compliance with GMP/ regulatory requirements
Provide technical support, process control and process improvement activities to support validation activities
Manage and guide the unit through team leaders
Performance management of direct reports and unit

Responsibilities
Planning and Unit Management

Provide technical and operational input during the drafting of processes, policies and procedures for unit
Monitor implementation of operational plan by team
Manage operational budget of the unit
Ensure availability and optimal allocation of resources to achieve operational objectives
Perform human resource functions for optimal management of unit

Validation

Ensure validation plans, SOPs and protocols are compiled and implemented to always ensure continued compliance
Manage validation activities within value stream validation programme according to validation plan/ schedule
Evaluate results from executed validation protocols
Ensure validation protocols and validation reports for new equipment / systems are documented and compiled
Develop and implement re-validation plans
Maintain and audit compliant state of validation department
Review validation training requirements and implement training where necessary

Qualification

Manage qualification activities with QC and Production
Review and approve relevant qualification protocols as per SOP
Manage change controls to ensure compliant status of affected equipment is not compromised
Ensure documents and procedures to operate and maintain equipment are in place

Requalification

Review and approve re-qualification of equipment and utilities as per Protocol and SOP

Governance, Risk and Compliance

Oversee compliance within strategic and operating guidelines and policies for department(s)/ function(s)
Ensure recordkeeping complies with legal requirements and provide input into changes to policies in this regard
Provide recommendations for development of risk-based compliance systems in order to improve overall compliance performance of the organisation and/or department/function.

Requirements
Background/experience

Specific job skills

Competencies

Accountability & Decision Rights

Develop, communicate, manage and implement corporate and divisional strategic plans and budgets, policies and procedures

Independent Decisions relating to

Design and implementation strategy for programmes and processes
Interpretation and execution of and recommendations on policy/ procedure related modifications
Short- and long-term department schedules, quality, compliance and resource allocation
Operational objectives and work plans, and delegation of assignments