Senior Quality Engineer

 

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:

In this role, you will report to the Quality Engineering Manager this role is responsible for coordinating the necessary activities for ensuring the timely closure of internal/external quality issues / projects and to coordinate / drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement.

 

Essential Duties and Responsibilities:

• Interface with customers to ensure concerns/complaints are communicated and corrective actions are closed in a timely manner.
• Support new programs with respect to validation, data analysis and system implementation.
• Act as mentor to the business with respect to the use of Lean / 6 Sigma tools.
• Support internal audit function in order to monitor compliance / drive improvements.
• Manage and drive quality projects in support of continuous improvement.
• Trending and track of quality data to support quality improvements across the business
• Reacting and ensuring the timely closure of day-to-day quality issues e.g. CAPA / deviations and change controls.
• Complete batch / sample inspections and documentation in line with batch manufacturing rules and GMP requirements
• Support incoming inspection and controls as per GMP requirements.
• Batch paperwork review and final decision to release product for shipment.
• Facilitate risk assessments as required to ensure continuing compliance, safety and quality of our processes and products.
• Interface with other departments with respect to sharing of best practices.
• Monthly reporting of key performance indicators (KPI’s) and coordinating necessary activities to drive improvements or address adverse trends.
• Management of customer documents into the TGE Quality system i.e. drawings; purchase specification; quality agreements etc. and the training out of relevant personnel.
• Drafting and approving of quality documentation to meet TGE and Customer requirements i.e. Quality Specification Sheets (QSS), CAPA’s, deviations, defect library, raw material specification etc.
• Participate in the review of validation protocols and reports to ensure quality compliance.
• Executing internal and external process and system audits.
• Co-ordinate activities associated with change management and customer interaction.
• Interface with other departments on a daily basis.
• Analysing and reporting of key measures e.g., Ppk’s, Cpk’s, cost of quality, customer complaints, and internal/external quality results.

• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties at the request of the direct supervisor.
• Lead and manage a high performing team to deliver the defined business goals and objectives.
• Act in accordance with the company’s guiding principles and adherence to the corporate Code of Conduct.
• Identification and development of talent to include performance management and succession planning (in the West Talent Gateway).
• Coaching / development of reports using development and retention plans as appropriate.
• Responsible for the identification and development of talent, to include performance management, coaching and mentoring for high performance.

 

 

Basic Qualifications: 

• Must have a third level qualification in Engineering/Quality/Science.
• Must have a minimum of 5 years’ experience of working in a high volume manufacturing environment ideally in the m