Quality Compliance Officer

Location

Portsmouth, Hampshire | United Kingdom

Job description

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

We have a fantastic opportunity for a Quality Compliance Officer to join our growing team!

In this role, you will support manufacturing in achieving its quality targets and goals through the use of confirmed quality tools and techniques.

In this role, you will have the opportunity to:

• Responsible for hosting, organising and supporting of onsite / postal audits from customers / regulatory bodies, including relevant preparation, responses to audit findings and facilitation of action completion

• Responsible for the creation and maintenance of the internal audit schedule
• QA Key Performance Indicators reporting and trending
• Provide induction and refresher training on GMP/GDP for the site
• Organisation of the bi-annual Management Review Meeting and compilation of information

In addition to...

Electronic Documentation System:

• Manage efforts associated with the overall process flow/ logistics of the electronic data management system for Manufacturing/QC/Quality Documentation, Corrective/ Preventative Action, which includes elements such as timeliness of actions through the system, operating efficiency, and quality system compliance to ISO guidelines/ FDA Quality Systems regulations, including electronic records

Central Documentation Management:

• Work with Sr. Management to assure harmonisation of the Life Sciences and Pall International Quality Policy/Manual, including effective deployment.
• Assure quality system procedures reflect current practice (through audit program and periodic review of documentation), including compliance

Quality Key Performance Indicators:

• Create and distribute reports on progress against Key Performance Indicators assigned to the department

Corrective Action/Preventative Action Systems:

• Harmonise systems, including deployment, for formal tracking of corrective and preventative action across the site
• Working closely with the Quality Assurance Manager, develop meaningful management reporting of CAPA trends and associated corrective actions on periodic basis that summarises review of trends/ patterns, potential system deficiencies and bring these to the attention of sr. management as necessary
• Ensure CAPA requests are responded to in a timely and effective manner within (realistic) timeframes specified for completion
• Assure systems are in place for monitoring of corrective action effectiveness
• Publish quarterly product quality trend report communicating quality trends by product family and customer

Experience, Qualification & Competencies

• ISO 9001:2015(Quality Management System) auditing training
• Formal training on quality tools and techniques
• Systematic approach to problem solving
• Results oriented and process driven
• Customer focused

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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