Validation Projects Coordinator
Dalitso Holdings
Midrand, Gauteng, ZA
6d ago
  • To coordinate and monitor all project activities that involve the validation of new equipment, systems, processes, and facilities.
  • Minimum Requirements :

  • 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.
  • Core Competencies

  • 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
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