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Requisition ID: 69562
- Date: Apr 14, 2025
- Location: Sao Paulo, Sao Paulo, BR
- Department: Operations
- Description:
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
**Job Summary**:
- Reporting to the department lead 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. Leading by example on shift, guiding team members with operational activities and deputising for Shift Lead/ delegate if /when absent or unavailable (e.g. facilitate Tier 1 meetings, completing Shift handovers)
**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. requi