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Sr QA Associate EM J& J Beerse, Belgium

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 wants to participate in the quality transformation through innovative solutions for the production site of the future.

Job Description:

At the J& J Innovative Medicine SC Beerse/Olen site, different product types are being produced and released such as Steriles, Liquids & Creams and Transdermals.

The Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of Products at/from the Campus Belgium are carried out as required by GMP legislation.

Within this department, QA EMS (Environmental Monitoring Systems) is responsible to ensure compliance of the environmental monitoring program during the daily manufacturing activities within J& J supply chain Beerse/Olen (Environmental, Personnel, Cleaning and Disinfection).

As a Sr QA Associate Environmental Monitoring, you are responsible for the quality oversight of the Environmental Monitoring of Utilities and Classified Manufacturing facilities at the Beerse/Olen site. You drive the design and implementation of an Environmental Monitoring Program for new products/new equipment in compliance with the Regulatory Guidelines and latest industry standards.

Job Responsibilities:

• Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results and act as Quality Point of Contact.

• Assure Quality milestones and stage gate deliverables are achieved within the project timelines.

• Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.

• Ensure that deviations, CAPAs, Change Controls and trend reports are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.

• Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.

• With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by identifying opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.

• Remain current in knowledge and skills towards regulatory and industry trends related to Environmental Monitoring

• Act as spokesperson during Health Authority inspections and customer audits.

Job Qualifications:

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

• 2-5 years experience in Pharmaceutical Industry. Experience with sterile/aseptic/low bioburden manufacturing is an asset.

• Demonstrated ability to work independently while staying connected with key stakeholders.

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

• Strong analytical thinking skills, solution oriented thinking and able to work in a flexible way under time pressure. Ability to make risk-based decision under time pressure.

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

• Understands the business implications regarding quality positions and decisions

• Project management skills