QA Specialist Shopfloor

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Sassenheim, Netherlands Job Description: About Innovative Medicine    Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.  Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.  Learn more at https://www.jnj.com/innovative-medicine      Essential Job Duties and Responsibilities   The QA Shopfloor Specialist acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

Implement and execute AQL and related visual inspection tasks performed by the QA unit according to applicable standards and company procedures.     Execute quality oversight activities in manufacturing and other areas, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.    During execution of AQL/shopfloor activities, record and maintain accurate GMP documentation and report non conformances or deviations observed.    Reviews and approves routine GMP documentation for all components of the Quality system.    Reviews and approves release documentation for LVV, including QA review of electronic batch records and related documentation.    Reviews and approves Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2, N5 and N6), as well as the approval of Maintenance and Calibration related documents (as needed).    Reviews and approves validation protocols and reports, CSV documentation, change controls, validation assessments, URS and applicable lifecycle documentation (as needed).    Promotes improvement initiatives to set up , standardize and lean out QA processes within the team.    Provides Site support for local or global projects as an SME or QA core team member.     Engages in internal audits and inspections as an SME or in support functions.    Escalates serious quality, compliance and /or GMP incidents to management.         Minimum experience required for the position:   2 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in various Pharmaceutical companies.   Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations     Other Requirements   Knowledge of aseptic processing techniques and sterile manufacturing requirements    Strong written and