About this role
<p><span style="font-family:arial, helvetica, sans-serif">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? </span></p> <p><span style="font-family:arial, helvetica, sans-serif">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.</span></p> <p><span style="font-family:arial, helvetica, sans-serif">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.</span></p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H4 style="font-size:1.0em;margin:0.0px"><b>Job Summary</b></H4> </div><div><p><span style="font-family:arial, helvetica, sans-serif">In this role you will ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements. Developing and implementing continuous improvement programs covering production processes and quality management systems. Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Essential Duties and Responsibilities</b></H2> </div><div><p><span style="font-family:arial, helvetica, sans-serif">• Management of customer complaints</span><br><span style="font-family:arial, helvetica, sans-serif">• Lead and perform risk assessments and implement control plans.</span><br><span style="font-family:arial, helvetica, sans-serif">• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s </span><br><span style="font-family:arial, helvetica, sans-serif">• Support quality systems implementations and relevant training </span><br><span style="font-family:arial, helvetica, sans-serif">• Lead in Continuous Improvement of Quality processes</span><br><span style="font-family:arial, helvetica, sans-serif">• Interact and collaborate with Operations and other functions and West sites to support production and timely resolution of issues and investigations.</span><br><span style="font-family:arial, helvetica, sans-serif">• Host Audits</span><br><span style="font-family:arial, helvetica, sans-serif">• Complete supplier assessments</span><br><span style="font-family:arial, helvetica, sans-serif">• Ensure compliance with customer agreements and specifications</span><br><span style="font-family:arial, helvetica, sans-serif">• Perform Document Control tasks as required</span><br><span style="font-family:arial, helvetica, sans-serif">• Monthly and quarterly reporting of Quality KPIs</span><br><span style="font-family:arial, helvetica, sans-serif">• Participate in internal audit and Shop Floor audit program</span><br><span style="font-family:arial, helvetica, sans-serif">• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking. </span><br><span style="font-family:arial, helvetica, sans-serif">• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.</span><br><span style="font-family:arial, helvetica, sans-serif">• Compliance to all local site Environmental, Health and Safety regulations. </span><br><span style="font-family:arial, helvetica, sans-serif">• Compliance to all local site company policies, procedures and corporate policies.</span><br><span style="font-family:arial, helvetica, sans-serif">• Other duties as assigned</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Basic Qualifications: </b></H2> </div><div><p><span style="font-family:arial, helvetica, sans-serif">• Degree in a Quality, Science or Engineering or equivalent discipline</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Preferred Knowledge, Skills and Abilities</b></H2> </div><div><ul> <li><span style="font-family:arial, helvetica, sans-serif">Min 5 years previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Aseptic or sterile manufacturing experience is desired. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Review and approval of facility, equipment and process validation </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Analytical Method, Equipment/Process and Software Qualification </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Involvement in new product introduction or technical transfer activities.</span></li> <li><span style="font-family:arial, helvetica, sans-serif">Quality Auditing certification. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Lean/Six Sigma certification. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Supervisory experience.</span></li> <li><span style="font-family:arial, helvetica, sans-serif">Quality planning and communication skills. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Strong technical writing ability. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Ability to liaise with customers and suppliers in an informed professional manner.</span></li> <li><span style="font-family:arial, helvetica, sans-serif">Excellent IT, communication and interpersonal skills using current office technologies. </span></li> <li><span style="font-family:arial, helvetica, sans-serif">Ability to work on own initiative, coupled with involvement on cross-functional teams. </span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif;color:white">#LI-Hybrid</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Travel Requirements</b></H2> </div><div><div>10%: Up to 26 business days per year</div></div></div></div><p><span style="font-family:arial, helvetica, sans-serif"><strong>Pay Transparency:</strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif">The annual base salary range for this position is €63,200.00 - €80,500.00. Total target compensation is determined using objective and gender-neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.</span></p> <p><span style="font-family:arial, helvetica, sans-serif">This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.</span></p> <p> </p> <p>West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening. </p>