Manager QA Ops Aseptic Manufacturing, Transdermals & Secondary Packaging - 2406162103W

　　Description

　　We are looking for an employee that has 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, who can connect easily with our different business partners and is gets a lot of energy of developing young talent.

　　Job Description :

　　At the Janssen Supply Chain Beerse site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals.

　　The Janssen Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of 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 of QA Operations Aseptic Manufacturing, Transdermals & Secondary Packaging you will lead and manage the Quality Operations team supporting the manufacturing 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

　　Together with your team you support the daily quality operations within the manufacturing area:

　　the release of products

　　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

　　Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance

　　Continuity of supply: 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

　　Manage the writing and/or QA approval of GMP documents (work instructions, SOPs, …) to ensure QA oversight of the operational activities

　　Support the preparation, execution and follow-up of internal and external inspections

　　Ensure that the internal audits are executed and reported according to internal audit schedule

　　Manage, coach and develop a team of 8 quality experts reaching their quality, business and personal objectives

　　Establishing and maintaining effective working relationships with the different business partners

　　Job Qualifications :

　　University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)

　　5 years experience in pharmaceutical industry

　　In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release

　　Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures

　　Strong analytical thinking, risk assessment, managerial and leadership skills

　　Ability to provide operational leadership to meet business objectives in a highly dynamic business environment

　　Excellent communicator, ability to building a network and create win-win solutions

　　Understands the business implications regarding quality positions and decisions

　　Qualifications

　　University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)

　　5 years experience in pharmaceutical industry

　　In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release

　　Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures

　　Strong analytical thinking, risk assessment, managerial and leadership skills

　　Ability to provide operational leadership to meet business objectives in a highly dynamic business environment

　　Excellent communicator, ability to building a network and create win-win solutions

　　Understands the business implications regarding quality positions and decisions

　　For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

　　Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

　　Organization Janssen Pharmaceutica N.V. (7555)

　　Job Function Quality Assurance

　　Req ID: 2406162103W