Quality & Validation Coordinator
Posted on 2025-03-17
| Employer | Stratogo |
|---|---|
| Salary | 22000 |
| Category | Medical |
| Location | Western Cape / Cape Town |
Job Summary
Location: Salt Rock
Start Date: Immediate
The primary function of a Quality & Validation Coordinator the Safety, Health and Environment Coordinator (SHE Coordinator) is to implement and maintain the Quality Assurance program of the plant.
The secondary function of the Quality & Validation Coordinator is to lead and maintain and implement the validation program of the plant.
Minimum qualification required:
- Matric or NQF4 equivalent qualification.
- Diploma in a Quality or Science field, Analytical Chemistry, Biotechnology, Microbiology, or equivalent)
- Microsoft Office proficiency
- Must have a clear criminal record.
People skills:
- Teamwork and collaboration
- Effective communication and reporting
- Presentation Skills
Business Skills:
- Basic Mechanical knowledge
- Knowledge of regulations and compliance (GMP, SAHPRA, WHO, FDA, etc.)
Other Attributes
- Strong problem analysis and problem-solving skills
- Attention to detail and ability to implement quality and validation processes
- Planning and organizational skills
- Ability to ensure regulatory compliance and maintain documentation integrity
KEY PERFORMANCE AREAS
Quality Management
- Administer and maintain non-conformance and quality management systems, including Corrective and Preventative Action (CAPA), Non-conformance Report (NCR), change control and deviations.
- Ensure quality requirements are met by both internal and external audit, review of inspection reports and analysis of non-conformance reporting.
- Assist in vendor/contractor performance monitoring and ensure only appropriate vendors/contractors are utilized.
- Ensure quality plans are produced when required and meet regulatory requirements.
- Monitor and maintain internal quality standards.
- Assist with CAPA close -out for self-inspections.
- Assit with training material and training record.
- Document and maintain Quality records..
- Other quality-related duties as assigned by the Line- Manager.
Validation Lead Responsibilities (20%)
- Develop and maintain the Validation Master Plan (VMP).
- Lead and execute validation activities for processes, equipment, utilities, and cleaning validation.
- Develop and review validation protocols (IQ, OQ, PQ) and reports.
- Conduct risk assessments related to validation and ensure all validation activities are compliant with regulatory requirements.
- Ensure requalification and periodic validation review of critical systems and processes.
- Coordinate validation activities with production, engineering, and quality teams.
- Address deviations, CAPAs, and change control related to validation.
- Maintain validation documentation in compliance with regulatory expectations.
- Support audits and inspections by providing validation documentation and evidence.
Impact of Errors
- Non-compliance with safety regulations can lead to significant legal and financial consequences, including fines and operational disruptions.
LEVEL OF DECISION MAKING
- Moderate to Minimal, with significant decisions related to validation requiring higher-level approvals.
We are committed to locating the ideal job for you, so we kindly advise against paying for this service.
There are no costs associated with securing employment with us.
Quality & Validation Coordinator position available in Western Cape, Cape Town. This job position was posted by Stratogo. The job has been posted as a char8000 ad on 2025-03-17 at 01:05:16 in the Medical category
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