Job Description

The non-sterile operator- cleaning and equipment preparation, is responsible for supporting the effective manufacturing of sterile pharmaceutical products as per the production schedule, in line with specifications and with accurate batch documentation.

POSITION RESPONSIBILITIES

Percent of Time (sum of responsibilities should equal to 100%)

Primary responsibility for providing cleaning and sterilization services as per production schedule while ensuring they meet all relevant targets including line OEE, Quality, right first time, adherence to schedule, health & safety.20

Responsible for Booking in, storage and distribution of the cleanroom garb and maintenance of consumables stocks in all areas, e.g. cleanroom supplies20

Providing cover for manufacture, sampling and dispensing of batches. Supporting the formulation, filling and packing process.25

Effectively resolve or escalate problems in the manufacturing area to ensure problem solving can occur when and where issues happen5

Completion of all relevant documentation, batch EBR (electronic batch record) and training records5

Attend and contribute to line meetings / daily huddles and visual workplace meetings for their lines / rooms. Identify improvement opportunities and contribute to continuous improvement projects.5

Attend and contribute to line meetings / daily huddles and visual workplace meetings for their lines / rooms. Identify improvement opportunities and lead / contribute to continuous improvement projects.5

Work effectively with their colleagues through timely and relevant communication to ensure the shift meets its production goals and that a smooth handover exists between shifts.5

Assist in 5S activities and help sustain the required 5s standards within their area.5

Organize, prepare for, and participate in Line Changeovers in order to maximize the OEE potential5

ORGANIZATIONAL RELATIONSHIPS

• Production Lead
• Production Operator
• Warehouse Personnel
• Quality Personnel

EDUCATION AND EXPERIENCE

• Experience in a pharmaceutical environment desirable.
• Knowledge and understanding of cGMP principles and manufacturing desirable.
• Lean manufacturing experience desirable.

PHYSICAL POSITION REQUIREMENTS

Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.

Lifting, sitting, standing, shift-hours.

Full time

Regular

Colleague

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