Overview
Quality Coordinator – Pharmaceutical Manufacturing Jobs in Bellville, South Africa at Progressive International – Global Recruitment #miningjobs #engineeringjobs #Remotejobs #financejobs
Position: Quality Coordinator – PHARMACEUTICAL MANUFACTURING
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, maintain, and implement the validation program of the plant.
Qualification And Experience
Matric
Diploma in a Quality or Science field (Analytical Chemistry, Biotechnology, Microbiology, or equivalent)
Microsoft Office proficiency
Basic Mechanical knowledge
Knowledge of regulations and compliance (GMP, SAHPRA, WHO, FDA, etc.)
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 audits, 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.
Assist with training material and training records.
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.
Desired Skills
Quality assurance
Quality inspections
Regulatory compliance
SAHPRA
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Title: Quality Coordinator – Pharmaceutical Manufacturing
Company: Progressive International – Global Recruitment #miningjobs #engineeringjobs #Remotejobs #financejobs
Location: Bellville, South Africa
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Engineering, Quality Technician/ Inspector)
