Job Description

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

ResponsibilitiesPlanning 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

• Minimum of Bachelors Degree and10 years related experience
• Management experience
• Experience in validation techniques in a Pharmaceutical Industry

Specific job skills

• Advanced understanding of Qualification and Validation principles
• Knowledge of control, instrumentation and electrical systems
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Translating strategy
• Interpreting and internalising information
• Interrogating information
• Offering insights
• Managing performance

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

Aspen Pharmacare