REPORTING TO:  

Quality Systems Manager

QUALIFICATIONS: 

Science Degree or equivalent

EXPERIENCE:

At least 2 years experience in validating equipment and/or processes in a regulated environment

KNOWLEDGE:

• Knowledge of  FDA/ ISO/ cGMP regulations
• Knowledge of writing scientific documentation

SKILLS:  

• Good organisational skills.
• Good interpersonal skills.
• Good problem-solving and decision-making skills.
• Attention to detail.
• Good writing skills.
• Self –motivation.
• Capable of working independently. 
• Initiative
• Ability to work as part of a team.

TASKS AND RESPONSIBILITIES: 

• Organisation and implementation of all validation activities at Biotrin. 
• Organisation and implementation of equipment calibration and maintenance programme at Biotrin.
• Documentation of all activities to required standards
• Evaluation and review of equipment service contracts
• Staff training on equipment and validation issues
• To provide leadership and initiative on validation projects, and to communication validation requirements effectively in FDA/ ISO approved environment