Sr QA Associate Environmental Monitoring

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

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 IM SC Beerse 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 (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 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 i...