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Quality Control Manager
Middelburg, Mpumalanga
Permanent
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Posted 11 September 2018

Job Details

Job Description

QUALITY CONTROL MANAGER

Overview:

To ensure compliance to current Good Manufacturing Practices throughout the company in order to produce quality products. To ensure control over release specifications, sampling, validations, environmental monitoring and regular audits of QC Laboratories.

 

Duties:

Documentation:

  • Review and approve Weekly reports
  • Review and approve Certificates of Analysis from suppliers

Validations:

  • Asses new equipment for validation requirements
  • Assess re-validation period / requirement
  • Review and approval of validation protocols
  • Review and approval of validation studies
  • Review of Product development results

Sampling:

  • Ensure QC sampling of materials, packaging and reagents are performed correctly and ahead of planned productions
  • Approve QC sampling forms
  • Communicate / coordinate with laboratories regarding Out of Specification investigations.
  • Ensuring results of QC samples are within the specifications
  • Confirmation of invoices once QC results are received

Environmental Monitoring:

  • Microbiology
  • Temperature
  • Coordinate, Review, Document and Release Micro and Temperature results

Quality Control:

  • Review and release the following:
    • Master release specifications
    • Analytical Protocols
    • Materials, reagents, etc
    • Packaging materials
    • Production consumables
    • Cleaning materials
    • QC results
    • Micro results
    • Stability results

Production:

  • Ensure production adheres to QC

Maintenance:

  • Review and approve results of:
    • Calibrations
    • Validations of equipment
    • HVAC and AHU’s
    • Nitrogen Gas Line
    • Compressed Air
    • Microbiological

 

Qualifications and experience:

B.Sc (Chemistry / Microbiology)

Professional registration – SACI, etc

Minimum 4 years Pharmaceutical QC experience as a Supervisor or Manager
Excellent QC and GMP knowledge

Remuneration:

Neg market related salary