Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Objective:

Responsible for review and verification of all documentation related to finished good Products and highlighting any inconsistencies or problems with the quality or compliance prior to final product release. Also responsible for supporting where required daily activities of Core QA department.

Essential Functions:

• Maintain solid understanding of Regulatory and Quality System requirements (ISO13485/FDA CFR).
• Prepare new SOPs and edit/delete revised Standard Operating Procedures
• Review of all batch manufacturing documentation, required in advance of final product release
• System data entry and data checks
• Compile customer documentation packages
• Provide customer facing responses to all level of inquiry
• Utilise Trackwise system – non conformances, deviations, CAPA
• Provide training and support to other QA staff as required as well as other departments within operations.
• Participate in personal development to further improve skills and knowledge relevant to the position.
• Utilise the Oracle system
• Record archiving. Routine filing and responsible for housekeeping of all quality document storage areas
• Appropriate PPE must be worn and used in accordance with the instructions provided to them
• May be required to perform other related duties as the need arises and/or assigned.

Education:

• Minimum of HND in Quality or Science preferable.

Experience:

Requires a minimum of two year's QA/QC experience in a relevant environment. Knowledge of computer applications and current software (Word/ Excel) is essential.

Contacts:

Will liaise extensively with all other departments on matters relating to quality and service in order to uphold the Company’s dedication to Customer satisfaction. This involves working with people at all levels within the organisation as well as external customers and regulatory bodies. 

Working Conditions:

Works in an office environment but may be required to spend some time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks.