Job Summary

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 using Kanbans and automated MES and Plc based systems, to ensure optimum equipment uptime and target outputs.
• Equipment includes, but not limited to -washers, autoclaves, envision, envision tooling, inner pack, outer pack-staging/ material handling, mixing-weighing, drop mill, feed mill, calendar, winder, rotocure and slitter machines). (advisable 4 stations)
• Train/mentor new and existing operators in production areas.
• 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, ensuring correct documentation is available and or provided.
• 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.
• Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, A3/A4
• Supporting deviation management - and drafting DATs.
• Support with batch card corrections and actively work with QA to improve right first time.
• Project Involvement – lead/ participate in projects as assigned by Area Manager/ Shift lead.
• 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.

Additional Responsibilities

Education

• High School Diploma preferred

Work Experience

• Minimum 3 years experience in the Bio Pharmaceutical /Pharmaceutical or Medical Device Industries, or in another GMP setting. required

Preferred Knowledge, Skills and Abilities

• Knowledge of Good Manufacturing Practises (cGMP) requirements would be an advantage
• Shift work
• 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

Physical Requirements