Title:  Operador de Produção

Job Summary

This role is primarily responsible for the production of product that meets or exceeds pre-determined specifications. Responsible for manufacture, inspection, packaging, labelling and completion of documentation necessary to provide quality, production and traceability records in accordance with Quality Systems and Environmental Management Systems.

Essential Duties and Responsibilities

• Manage production flow and output, by carrying out a range of functions including tracking product at each stage of the process, proper labelling and inventory management to ensure optimum equipment uptime and target outputs.
• Train/mentor new operators
• Adhere to standard operating instructions for proper PPE and gowning for entry to production, quality, labs and clean room areas.
• Prepare, set-up and clean machines as per requirements. Adhering to housekeeping and materials management policies in all production areas while focusing on continuous process improvement using Lean Principles.
• Clean room cleaning, organizing and adherence to cleaning schedules.
• Gather, record and label samples for testing by QA and Lab departments. Ensuring correct documentation is available and or provided.
• Carry out product testing and records results as required.
• Maintain process equipment, assisting and completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
• Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various systems; ensure all work is carried out in line with same.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Understand the specific responsibilities of all departments as they relate to one’s own department, understanding the business processes one’s department supports.
• Work collaboratively to drive a safe and compliant culture. Compliance to all local site Environmental, Health and Safety regulations.
• Adheres to methods/procedures and policies to meet the requirements of Quality Systems and Environmental Management Systems.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

Education

Complet hight school degree

Preferred Knowledge, Skills and Abilities

• Knowledge of Good Manufacturing Practises (cGMP) requirements would be an advantage
• Proficiency in Microsoft Office and job related computer applications
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Must be able to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and process specification, and ensure that all associated paperwork is completed accurately.
• Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant personal protective equipment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Self-motivated
• Effective time management and multi-tasking skills
• Excellent attention to detail
• Trouble shooting skills
• Goal/ results orientated
• Good verbal reasoning, numerate ability
• Proven ability to work in a team environment