Validations Coordinator, Midrand

• To support the overall Validation Program by conducting qualifications and preparing and/or executing validation documents. This includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls. Validation systems are in place and used to control/ guarantee the quality of products.

Responsibilities of the Role:

• Execute-validation documentation in line with the standard approval process/protocols
• Maintains matrices for all departments
• Communicate and liaise with all stakeholders
• Implement process improvement initiatives
• Perform root cause analysis of system failures
• Updating existing quality documentation
• Identifying training requirements
• Maintains accurate and complete safety /GMP records with company policy and legal requirements
• Administers troubleshooting efforts for protocol discrepancies
• Identify process gaps and apply process improvement methodologies
• Plan, prioritize process improvement initiatives
• Explores process improvement opportunities
• Identify and communicate any skills/training requirements to help execute tasks efficiently.
• Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standards
• To ensure that new and updated Guidelines and Policies from SAHPRA 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
• To ensure that all validation related audit points identified during audits are closed timeously
• Write, review Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on process validation.

Minimum Requirements:

• Bachelor's Degree in Science/Engineering or a related discipline
• Experience in pharmaceutical industry with the manufacturing environment
• At least 2 years in a Validation Department
• Good working knowledge of manufacturing equipment, process, facility, utilities and computerised system validation
• Proficiency in MS Office (Word, Excel, PowerPoint and Project management)
• Ability to interpret and relate validation guidelines and standards for implementation 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, Root Cause Analysis, Failure Mode effects analysis, etc.

Core Competencies:

• Presenting and communicating information
• Applying expertise and technology
• Following instructions and procedures
• Coping with pressure and setbacks
• Adhering to principles and values
• Adapting responding to change