Validation Manager

5 days ago

Port Elizabeth, South Africa Aspen Pharma Group 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**
- Minimum of Bachelor’s 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

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