SCOPE:
This position requires a detail oriented individual capable of working independently in a clean room environment and meeting the demands of production timelines and commitments.
PRIMARY RESPONSIBILITIES:
· Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
· Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, product release, etc.
· Authorize release of approved material, intermediates and finished product
· Prevent release of suspect or known nonconforming products and materials
· Perform microbiological testing of environment and products as necessary
· Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices
· Follow detailed process steps without deviation.
· Organize reports, files, and results in a professional proficient manner.
· Conduct training to Quality Systems processes as defined within the Sirtex learning management system.
· Be flexible and work within a small team without strictly defined roles to assure complete functional coverage
EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:
· GCE‘A’ levels, diploma or equivalent
· Fluent in English (read, write and speak)
· Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment
· Previous experience handling chemicals and using basic chemical laboratory equipment preferred but not required.
· Previous experience working in a medical device, pharmaceutical, or other regulated industry preferred but not required.
· Personable, energetic, responsive and confident
· Good organization and time management skills
· Good communication skills and able to interact effectively with all levels
· Strong interpersonal skills and a good team player
· Basic office computer skills (email, word processing, and spreadsheet software)
· Ability to work on weekends and public holidays is required