Manager QA Operations Liquids & Cremes JSC Beerse, Belgium

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We are looking for an employee that is having a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for an employee that likes to work with people, is connecting easily with our different business partners and is getting a lot of energy of developing our young talent. Job Description: At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Do you want to contribute to the manufacturing of life-changing products for our patients and be part of an engaged and inclusive team at Janssen Supply Chain Beerse? At the JSC Beerse site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals. The site in Olen, where pellet formulations are being produced, is falling under the same entity/management responsibility. The Janssen Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of Investigational and Commercial Products at/from the Campus Belgium are carried out as required by GMP legislation. Within this department, the QA Operational group is responsible to ensure compliance during the daily operational aspects in the production plants. As manager QA Operations Liquids & creams you will lead and manage the Quality Operations team supporting the Liquids and creams area to assure the safety, efficacy and timeliness of product supplied to patients via the deployment of suitably qualified / validated manufacturing, testing, distribution and management processes, and to satisfy all internal and external regulatory expectations Your main responsibilities include: Together with your team you support the daily quality operations within the aseptic manufacturing area: the release of products the review of batch documentation support and approval of investigations and related capa’s Review and approval of change controls Review and approval of validation documentation Handle customer complaints Attend tier 1-tier 2 meeting within the production plant Approve APR (annual product reviews) Prepare and attend monthly QIP (quality improvement plan) meetings You continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance You support the continuity of supply: you interface daily with Planning, Manufacturing, Packaging, QC and Supply Chain groups to assure that adequate resources are available to support the twin goals of customer service and inventory minimization, report on resources issues and operating constraints You manage the writing and/or QA approval of GMP documents (work instructions, SOPs, …) to ensure QA oversight of the operational activities You support the preparation, execution and follow-up of internal and external inspections and act as a spokesperson for your areas of expertise You ensure that the internal audits are executed and reported according to internal audit schedule As a people manager you manage, coach and develop a team of 7-8 quality experts reaching their quality, business and personal objectives You establish and maintain effective working relationships with the different business partners Qualifications About the candidate: You have a master’s degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering). Qualification as a QP is a benefit You have at least 5 years of working experience, preferably in the Chemical/ Pharmaceutical industry You have in depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release You have thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures You are a strong analytical thinker who applies risk based decision making You understand the business implications regarding quality positions and decisions You are able to provide operational leadership to meet business objectives in a highly dynamic business environment You are an excellent communicator, able to create a network and create win-win solutions You are a passionate and engaging people leader, capable of managing the various aspects of leadership and personnel strategy. You are fluent in both spoken and written Dutch and English. Equal Opportunity Statement: The employers of the J&J family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where people feel at home and are given the space to realize their full potential. Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function Quality Requisition ID 2105967666W