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. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
Location: Belgrade, Serbia
YOUR responsibilities & YOUR impact:
- The BQ Specialist is responsible for the quality of, and meeting the applicable requirements for, services and the products marketed by the LOC.
- Also responsible for business Contract Management and Operational Portfolio Management, and provides support to Regulatory Affairs in the LOC.
- Implement, maintain and monitor the quality system for the LOC:
- Ensure the provision of appropriate training for regulated activities in the LOC
- Ensure appropriate management of non-conformances related to GxP: internal and external change controls, internal and external CAPAs, events, deviations.
- Leading / coordinating for auditing and inspection
- Monitor quality system performance versus local GxP and J&J requirements
- Provide input to the Quality Head for the bi-annual Management review
- Notify and engage SE Cluster Quality Head and Business Quality Regional and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures.
- Ensure appropriate qualification and monitoring of suppliers in the LOC
- Processing Product Quality Complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner.
- Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes
Support to local organisation
- Functions as Regulatory Affairs back-up in the absence of the Regulatory Head.
- Communicate with legal department and business in relation to creation of new or changes in existing commercial agreements; capture commercial conditions or their changes within legal timeframe, share the agreements with all stakeholders and customers and keep ICD (international Contract Database) regularly updated.
- Takes care about Operational Portfolio Management (OPM) – initiates requests for SKU delisting/new SKU creation, keeps product lists/price lists up to date with active SKUs – in collaboration with local business, regulatory, customer service and supply teams
We would love to hear from YOU, if you have:
- Education: University / Bachelor’s Degree or Equivalent, preferably in Pharmacy/Medicine or Quality Management related field
- At least 2 years’ experience in Pharmaceutical Industry, ideally in area of Business Quality, Regulatory Affairs and/or Pharmacovigilance
- In depth knowledge of pharmaceutical legislation and GMP/GDP
- Excellent interpersonal, partnering and negotiation skills
- Ability to navigate and produce results in a global, matrix organization, strong cross-departmental support, interdisciplinary approach
- Strong customer focus and service orientation
- Fluent knowledge of Serbian and English
- 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
Johnson & Johnson S.E., Inc. Slovenia (7395)