Validation Manager

2 months 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 Officer

    1 month 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,...

  • Validation Officer

    2 weeks ago

    Port Elizabeth, South Africa Fresenius Group Full time

    Job title : Validation Officer Job Location : Eastern Cape, Port Elizabeth Deadline : December 08, 2024 Quick Recommended Links Jobs by Location Job by industries General Duties: Development of User Requirement Specifications Development of Manufacturing Procedures Qualification and re-qualification of equipment and utilities ...

  • Validation Team Leader

    3 months 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...

  • Agricultural Management Professional

    40 minutes ago

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

    Are you a motivated and experienced agricultural professional looking for a new challenge? Do you have a strong background in livestock nutrition and management?Farm Manager SA is seeking an exceptional Agricultural Management Professional to join our team. In this role, you will be responsible for developing and implementing nutrition plans for farms,...

  • Livestock Production Specialist

    4 weeks ago

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

    Farm Manager SA is seeking an experienced and skilled Farm Manager to oversee the day-to-day operations of our beef and sheep farming operation. This is a unique opportunity to work in a dynamic and fast-paced environment, utilizing your expertise in livestock management to drive business growth.About the RoleThe successful candidate will be responsible for...

  • Livestock Nutrition Consultant

    40 minutes ago

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

    At Farm Manager SA, we are seeking a highly skilled Livestock Nutrition Consultant to join our team. The successful candidate will have a strong background in agricultural management, with at least 3 years of experience in a leadership position.We offer a competitive salary of approximately $120,000 per annum, depending on location and experience.Key...

  • Farm Sales and Service Representative

    33 minutes ago

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

    Job Title: Farm Sales and Service RepresentativeAbout Farm Manager SAFarm Manager SA is a leading provider of farm management services to farmers across South Africa. We are currently seeking a farm sales and service representative to join our team.Job DescriptionIn this role, you will be responsible for providing exceptional customer service to our clients...

  • Feedlot and Pastures Specialist

    37 minutes ago

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

    Farm Manager SA is committed to excellence in agriculture and is seeking an experienced Feedlot and Pastures Specialist. This is a unique opportunity to work with our team and contribute to the success of our clients.The successful candidate will have a strong understanding of agricultural principles and practices, with a minimum of 3 years of experience in...

  • Livestock Industry Professional

    37 minutes ago

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

    Job Title: Livestock Industry ProfessionalAbout Farm Manager SAFarm Manager SA is a dynamic and growing company that provides farm management services to farmers across South Africa. We are currently seeking a livestock industry professional to join our team.Job DescriptionThis is an exciting opportunity to work in the fast-paced livestock industry,...

  • Agricultural Sales Specialist

    45 minutes ago

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

    Job Title: Agricultural Sales SpecialistAbout Farm Manager SAWe are a leading farm management company seeking an experienced agricultural sales specialist to join our team. In this role, you will be responsible for promoting our farm products and services to customers.Salary and BenefitsThe estimated annual salary for this position is R250,000 - R350,000,...

  • Agricultural Business Development Representative

    1 month ago

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

    Job Description:Farm Manager SA is seeking a highly skilled and motivated Agricultural Business Development Representative to join our team. In this role, you will be responsible for developing and maintaining relationships with dairy farmers in the province.About the Role:This is an exciting opportunity for someone who is passionate about sales, has...

  • Technology Transfer Manager

    4 months 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...

  • Operations Manager

    4 months ago

    Port Elizabeth, South Africa The Host Management Full time

    Operations manager to oversee Short term rentals based in Summerstrand **Duties**: Run and manage Airbnb apartments Strong organisational skills Hospitality experience (Crucial) Own vehicle or valid drivers license (Crucial) Pay: R11 000,00 - R13 000,00 per month

  • Microbiologist Lab Manager

    4 months 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...

  • Logistics Operations Manager

    5 days ago

    Port Elizabeth, Eastern Cape, South Africa Work Africa Full time

    Courier Operations Supervisor Job DescriptionWork Africa seeks a skilled Courier Operations Supervisor to manage day-to-day operations, ensuring timely and efficient delivery of packages. The ideal candidate will have logistics/distribution supervisory experience, a valid Code 08 License, and excellent communication skills.Key Responsibilities:Dealing with...

  • Operations Manager

    3 months 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...

  • Operations Manager

    3 days ago

    Port Elizabeth, South Africa Jobted ZA C2 Full time

    Our client is seeking an experienced and driven Operations Manager to oversee and optimize the daily operations of their retail and warehouse facilities. The ideal candidate will possess a strong background in retail management, warehouse operations, security, human resources, risk management, and fleet management. This is an excellent opportunity for a...

  • Project Manager Civil Engineer

    35 minutes ago

    Port Elizabeth, Eastern Cape, South Africa Staff Solutions Recruitment Full time

    Job Title: Project Manager Civil EngineerSalary: R 800,000 - R 1,200,000 per annumCompany OverviewStaff Solutions Recruitment is a leading recruitment agency specializing in placing top talent in various industries.Job DescriptionThe successful candidate will oversee the implementation of water conservation and demand management initiatives, lead and manage...

  • Vehicle Sales Manager

    1 month ago

    Port Elizabeth, South Africa On Line Personnel Full time

    Job Position: Vehicle Sales Manager Ref: 4741 Location: PE/Gqeberha Salary: Competitive salary + benefits Email your CV to Qualifications / Requirements: • Minimum of Matric • Proven Used vehicle sales management experience essential – will need to supply confirmation of exceeding targets • Valid drivers license • Dynamic, resilient,...