General Employment - Other General Employment
- To coordinate and monitor all project activities that involve the validation of new equipment, systems, processes, and facilities.
- Bachelor's degree in Engineering or a related discipline
- 5 – 10 Years’ Experience in Pharmaceutical Validation
- Experience in Project Management
- Good working knowledge of Validation and Qualification in the Pharmaceutical industry
- Excellent technical writing and verbal communication skills
- Ability to read/interpret validation and engineering documents.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project management
- Ability to interpret and relate Validation standards for implementation and review to functional areas.
- Demonstrated ability to provide technical solutions for problems through process knowledge.
- Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
Summary of Job Outputs:
- Ensure that the protocols are executed and that the recommendations are implemented.
- Manage technology transfer activities between the stakeholders (Technology suppliers and Technology receiver)
- Maintain project documentation and ensure that appropriate documentation is closed at project closure.
- Maintain in Project documentation and keep up to date with the Regulatory Requirements (SA GMP Guidelines, EMA, WHO, ISPE) through, training and research
- Identify and communicate any skills/training requirements to help execute tasks efficiently.
- Maintain accurate and complete safety /GMP records with company policy and legal requirements.
- Administer troubleshooting efforts for protocol discrepancies.
- Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standards.
- Ensure that new and updated Guidelines and Policies from MCC and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentation.
- Interface with customers to ensure concerns and complaints are communicated and corrective actions are closed in a timely manner.
- Ensure that all validation related audit points identified during audits are closed timeously.
- Identify process gaps and apply process improvement methodologies.
- Obtain quotations from service providers and ensure Purchase Orders are issued before the work is executed.
- Use project scheduling and control tools to monitor project plans.
- Track and manage change controls together with the technology transfer team.
- Delivering Results and Meeting Customer Expectations
- Planning and Organizing
- Applying Expertise and Technology
- Coping with Pressure and Setbacks
- Achieving Personal Work Goals and Objectives
- Adhering to Principles and Values
- Relating and Networking
- Presenting and Communicating Information