Applications are invited from suitably qualified and experienced candidates to fill the post of:
QUALITY SYSTEMS OFFICER
Key Duties & Responsibilities
1. Development of Equipment Master Plan validation timelines for manufacturing and QC Lab equipment.2. Development of User Requirements Specification documents for manufacturing and QC Lab equipment and utilities.3. Development of Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification protocols, their execution and report writing.4. Carries out risk and impact assessment on systems and on any proposed changes to validated systems.5. Qualification of facilities, utilities and equipment (HVAC, Water, Compressed air, steam e.t.c.).6. Maintenance of the ‘Validated State’ for equipment and utilities.7. Participates in complaints, deviations, changes, CAPA, audits and other cGMP related issues.
Minimum Qualifications and experience:• Degree in Mechanical Engineering or Pharmaceutical Engineering or Mechatronics Engineering.• Sound knowledge of current Good Manufacturing Practices.• 2 years professional experience in the pharmaceutical industry will be an added advantageApplications in writing together with a detailed CV must be sent to: [email protected]
CLOSING DATE: 27 NOVEMBER 2018
Job Summary
Location
Category
Engineering