Validation Manager

7 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

  • Validation Manager

    1 week ago

    Port Elizabeth, Eastern Cape, South Africa Jobs2day SA Full time

    Job DescriptionThe Sterility Support & Validation Manager is responsible for the management of the validation section and coordination of the total validation project.Key Responsibilities:General Section Management, including activity planning, coordination, execution, and control.Maintenance of department efficiency through principles of supervision and...

  • Validation Manager Specialist

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Headhunters Full time

    Sterility Support and Validation ManagerJob Summary:We are seeking a highly experienced Sterility Support and Validation Manager to join our team in Port Elizabeth. The successful candidate will be responsible for ensuring the company's products meet the highest standards of quality and safety.Responsibilities:Developing and implementing a comprehensive...

  • Validation Officer

    1 week ago

    Port Elizabeth, South Africa Fresenius Kabi Full time

    Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. The main purpose of the Validation Officer is to prepare, plan, co-ordinate,...

  • Senior Manager Validation and Sterility

    6 days ago

    Port Elizabeth, Eastern Cape, South Africa Headhunters Full time

    Sterility Support and Validation ManagerHeadquartered in Port Elizabeth, our client in the Pharmaceutical Industry is seeking a highly skilled and experienced Sterility Support and Validation Manager to join their team.The ideal candidate will possess a Life Science or Engineering degree and have 5-10 years of direct Validation Management experience in the...

  • Sterility Support

    3 weeks ago

    Port Elizabeth, South Africa Fresenius Kabi Full time

    Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. The main purpose of the Sterility Support & Validation Manager is the management...

  • Quality and Validation Lead

    1 week ago

    Port Elizabeth, Eastern Cape, South Africa Jobs2day SA Full time

    Job SummaryThe Sterility Support & Validation Manager will be responsible for leading the validation section and coordinating the total validation project.Responsibilities:Validate equipment, processes, and systems to ensure they meet regulatory requirements.Develop and implement written procedures for validation, qualification, and calibration.Manage and...

  • Validation Team Leader

    7 days ago

    Port Elizabeth, South Africa Aspen Pharma Group Full time

    **Overview** - Facilitate and supervise validation exercises - Provide technical support, process control and process improvement activities to support validation activities. - Assist with validation activities. - Performance management of direct reports **Responsibilities** **Planning and Section Management** - Execute and implement policies and...

  • Validation Specialist Sterility Support

    6 days ago

    Port Elizabeth, Eastern Cape, South Africa Headhunters Full time

    Sterility Support and Quality Assurance RoleOur client in the Pharmaceutical Industry is seeking a highly skilled and experienced Sterility Support and Validation Manager to join their team in Port Elizabeth.The ideal candidate will have a Life Science or Engineering degree and 5-10 years of direct Validation Management experience in the pharmaceutical...

  • Dairy Manager

    1 week ago

    Port Elizabeth, South Africa Farm Manager SA Full time

    **Port Elizabeth Area (Western Cape side) Eastern Cape**: Our client is looking for a Dairy Manager to join the team. **MINIMUM REQUIREMENTS** - ** **Agricultural Diploma/Degree highly advantageous - Min of 4 years previous dairy experience - Min of 4 years previous pasture management experience - Proven AI Ability - Computer literate - Being...

  • Maintenance Manager for Cookhouse Area

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Farm Manager SA Full time

    At Farm Manager SA, we are seeking a skilled and experienced Junior Maintenance Manager to join our team. The ideal candidate will be responsible for managing maintenance activities and ensuring smooth operations.Key Responsibilities:Oversee maintenance activities and optimize workshop functions.Lead the team and foster a culture of safety and...

  • Maintenance Coordinator Job Opening

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Farm Manager SA Full time

    At Farm Manager SA, we value our employees and strive to provide a safe and healthy work environment.Job Summary:The Junior Maintenance Manager will be responsible for managing maintenance activities and ensuring smooth operations.Key Responsibilities:Oversee maintenance activities and optimize workshop functions.Lead the team and foster a culture of safety...

  • Mechanical Trade Specialist

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Farm Manager SA Full time

    **Job Overview**Farm Manager SA is seeking a highly skilled Boilermaker to join their team in the Cookhouse Area of the Eastern Cape.The successful candidate will have a strong background in mechanical trade and experience working in a manufacturing environment.Minimum 3-5 years post-apprenticeship experience as a Boilermaker;Valid driver's license;Able to...

  • Production Manager

    1 week ago

    Port Shepstone, South Africa Farm Manager SA Full time

    **Port Shepstone Area - KwaZulu Natal**: Our client is looking for a Production Manager to join the team. The suitably experienced/qualified person would be responsible for the daily planning, organization, supervision and administration of all production activities across the banana and macadamia farming operations **MINIMUM REQUIREMENTS** - Relevant...

  • Quality and Sterility Manager

    6 days ago

    Port Elizabeth, Eastern Cape, South Africa Headhunters Full time

    Validation and Sterility Management PositionWe are looking for a highly motivated and experienced Sterility Support and Validation Manager to join our team in Port Elizabeth.The successful candidate will have a Life Science or Engineering degree and 5-10 years of direct Validation Management experience in the pharmaceutical industry. They should also possess...

  • Technology Transfer Manager

    6 days ago

    Port Elizabeth, South Africa Fresenius Kabi Full time

    Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. The main purpose of the Technology Transfer Manager is to enhance and optimize the...

  • Microbiologist Lab Manager

    6 hours ago

    Port Elizabeth, South Africa Fresenius Kabi Full time

    Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. **Duties**: - Ensuring effective design, sampling and monitoring of all...

  • Production Manager

    3 weeks ago

    Port Elizabeth, South Africa Aspen Pharma Group Full time

    **Overview** - Manage and support production processes and outputs - Long term production and shift planning - Problem identification and solution engineering - Manage and guide production staff through team leaders - Performance management of direct reports, monitoring of performance management within department - Reviewing and approving production...

  • Operations Manager

    3 weeks ago

    Port Elizabeth, South Africa House of cleaning Full time

    **About us** We are professional. **Manage cleaning operations and liaise with clients to ensure quality service delivery**. Ensure teams adhere to safety measures during cleaning operations. Facilitate budget planning for smooth flow of operations. Evaluate relevant data to propose recommendations for cleaning process improvement. Must have knowledge of...

  • Transportation Manager

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa On Line Personnel Full time

    Job Overview:Fleet managers are responsible for overseeing the maintenance, tracking, and incident management of company vehicles.Key Responsibilities:Maintain vehicle records and ensure compliance with regulatory requirements.Monitor driver performance and take disciplinary action when necessary.Collaborate with drivers to resolve issues and improve overall...

  • Coega Accounting Manager

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Headhunters Full time

    Job Summary:">We are seeking a skilled Bookkeeper to manage the financial functions of our Engineering company. The successful candidate will have a strong background in accounting and bookkeeping, with experience in managing financial records and preparing financial statements.Key Tasks:Ensure that all data captured into the system is valid, accurate and...