Oversees the implementation of Standard Operating Procedures relating to equipment and critical systems, according to Good Manufacturing Practice (cGMP) requirements.
Monitors and controls sampling plan of Water, CAS and Nitrogen systems.
Initiates and participates in risk assessment processes related to critical systems, equipment and information systems.
Participates in projects relating to equipment, critical systems and information technology .
Manages investigations of deviations related to equipment and critical systems, ensures that the deviations are reported, investigated and their effect on product is assessed and documented. Ensures that corrective and preventive actions are implemented and are effective.
Ensures the correct implementation of the change control procedure relating to equipment and critical systems as to assess and prevent unintended adverse consequences resulting from changes.
Bachelor’s Degree in Chemistry, Engineering, or related field
8+ years of cGMP/Quality from manufacturing facilities
Strong problem-solving skills
Significant knowledge on QA Systems SOP development and risk assessment techniques
Experience presenting QA systems topics during inspections
5+ years of managerial experience
Proven ability to understand complex processes/problems
Proven experience overseeing critical system, equipment and IT systems
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