Danaher Corporation Quality Compliance Officer in Portsmouth, United Kingdom
Danaher Company Description
Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.
Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.
Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.
To learn more about Pall, please visitwww.pall.com/green.
_Position Summary_ * Development and authoring of compliance systems and procedures * Auditing compliance program to ISO9001:2015 * Fronting and supporting of onsite / postal audits from customers / regulatory bodies including relevant preparation, responses to audit findings and facilitation of action completion * QA Key Performance Indicators reporting and trending * Communicate VOC to all levels of site in relation to regulatory requirements and industry expectations including site training for QA expectations (Such as GMP) * Other activities as required to support investigation of external complaints / Internal & Supplier Rejects and production Inspection & Approvals * Support customer factory acceptance testing as well as third party visits and approvals _Main Duties:_ * Electronic Documentation System o 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 o Work with Sr. Management to assure harmonisation of the Life Sciences and Pall International Quality Policy/Manual, including effective deployment. o Assure quality system procedures reflect current practice (through audit program and periodic review of documentation), including compliance * Quality Key Performance Indicators o Create and distribute reports on progress against Key Performance Indicators assigned to the department * Corrective Action/Preventative Action Systems o Harmonise systems, including deployment, for formal tracking of corrective and preventative action across the site o 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 o Ensure CAPA requests are responded to in a timely and effective manner within (realistic) timeframes specified for completion o Assure systems are in place for monitoring of corrective action effectiveness o Publish quarterly product quality trend report communicating quality trends by product family and customer Other Duties * Support Customer, Supplier, Regulatory and FAT site visits as directed by the Site Quality Assurance Manager * Customer facing during audits * Prepared to train staff or conduct new employee inductions * General Quality Support for the Module
_Knowledge & Key Skills:_ * Good Understanding of ISO9001:2015 and its requirements * Experience in trend analysis using statistical methods * Ability to communicate well (written and verbal), work well with others, assign tasks to other personnel that are not direct reports * Work with a high level of independence and practice effective decision making skills * Know when to escalate or seek clarification of goals, objectives and performance * Maintain an open mind and work effectively as a team leader within and outside the group to help motivate personnel, maintain a high level of employee morale, and foster a harmonious work environment * Excellent time management and Prioritization skills * Computer literate (MS Office suite). Some understanding of SAP would be advantageous * The following attributes would be advantageous o Understanding of the use of high tolerance measuring equipment o Knowledge of mechanical manufacturing processes * The following Qualifications/Education would be an advantage but not essential: o ISO 9001:2015 (Quality Management System) auditing training o Educated to HNC/HND level in Quality or Engineering discipline o Member of CQI Essential Previous Experience: * Must have experience in a QA role within the life sciences or Biopharm market * Experience of ISO9001 requirements * Knowledge of cGMP
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-United Kingdom-Hampshire-Portsmouth
Req ID: LIF003691