Senior Quality Engineer
West Pharmaceutical Services
- Dublin
- Permanent
- Full-time
- 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.
- 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 medical device / pharmaceutical sector.
- Must have a thorough understanding of statistics, SPC, and ideally the use of minitab.
- Must have an in-depth knowledge of validations in a medical device environment.
- Must have excellent communication skills both oral and written.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 / and EU GMP is considered an advantage.
- Must be able to prioritize and organise tasks.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times.
- A background in drug handling would be considered an advantage.
- A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Knowledge of EU GMP is considered a requirement for working in the Medical area.
- Ideally would have experience of third party and regulatory audits and the preparation of same.
- Ideally have an understanding of Environmental Management System ISO 14001.
- Ideally have a working knowledge of Lean / 6 Sigma tools. Green Belt certification in preferred.
- Must be able to travel up to 5% of the time.
- Must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
- Must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.
- Quality Engineering Manager