Johnson & Johnson Careers
Requisition ID: 1905746112W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.
Quality Assurance Pharmacist
Location: Budapest, Hungary
Contract: Fixed term contract (2 year)
The Quality Assurance is responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC. He/she is also responsible for compliance with elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP / GDP activities the LOC undertakes. He/she is responsible for the oversight of quality and compliance status of all third parties and other J&J organizations engaged by the LOC for the GMP / GDP activities for the LOC
· Implement, maintain and monitor the GMP/GDP part of the J&J quality system for commercial organizations in the LOC
· Maintain an up to date list of all relevant product sourcing, supply routes, product licenses, product lists, relevant authorizations and quality agreements.
· Execute requirements regarding lifecycle management of GMP/GDP related documents and record to ensure regulatory compliance and business continuity
· Ensure the provision of appropriate training for all regulated functions with GMP / GDP responsibilities
· Monitor and arrange oversight of actions under Deliver QA responsibility, or other third party used for transport and distribution
· Oversee the preparation, execution and follow up for the external inspections, and report these and any other relevant field action activity into relevant systems
· Monitor Quality system performance versus local GxP and J&J reuirements via use of pertinent business and compliance metrics and goals
Crucial Requirements for Candidates:
- Fluency in the national language and the English language is required
- University degree level at Life Science is required, University degree at Pharmacy is beneficial
- External Body Qualification as Internal Auditor is preferred
- At least 2 years experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP
- Strong analytical, communication, decision – making and leadership skills for interaction with external and internal customers and partners
In Return, We Offer:
· An opportunity to be part of a global market leader.
· A dynamic and inspiring working environment.
· Many opportunities to work on challenging projects and assignments.
· Possibilities for further personal as well as professional development.
· Many employees benefits.
Janssen-Cilag Kft. (8396)