RA Process & Compliance Professional - NEMA Job

Job description

RA Process & Compliance Professional
- NEMA-000011KWDescriptionJohnson & JohnsonCaring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace research and science
- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.Our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Johnson & Johnson Middle east covers 3 sectors: Consumer, Medical Devices and Diagnostics and Pharma. Generally covers Middle East, North Africa & Pakistan region, 37 countries; 300 employees across MENAP, with 37 Nationalities.
Aim of job:
- Support RA compliance in the region
- Execute and follow-up Quality Processes linked to RA activities
- Enable efficient operations of NEMA Regulatory AffairsMain accountabilities:
- Support RA compliance in the regiona. Act, where appropriate, as Super User/Subject Matter Expert for GRA Systems (including but not limited to: PKB, Trackwise, SPS, GRAIL, ERIS, WRAT) for problem solving and to support RA Experts in maintaining compliance for systems.b. Provide support for the effective use of the data held in GRA systems to support key business & Quality processes and to respond to ad-hoc requests (including but not limited to: inspections, audits and key operational business processes).c. Support Compliance oversight in the region by preparing dashboards and trend analyses of compliance data from GRA systemsd. Support compliance with the relevant SOP’s/WI’s, training requirements, change management procedures and regulations and be involved with the evolution of these documents and materials to meet changing business needs.
- Execute and follow-up Quality Processes linked to RA activitiesa. Initiation, coordination, monitoring and closure of change controls, deviations, CAPAs and escalationsb. Coordinate creation, review, approval and revision of RA controlled documentsc. Support preparation of metrics for Quality Management Review
- Enable efficient operations of NEMA Regulatory Affairsa. Support implementation of key RA processes and corresponding systems, including but not limited to: Planning & tracking, electronic archiving & information sharing (sharepoints/shared drives), onboarding Process, knowledge management and Regulatory intelligence.b. Assist with the development of new business support capabilities to meet the needs of the evolving Business and Regulatory environment.c. Support implementation of GRA/EMEA Best Practices and deployment of Global/regional projects related to compliance/operational efficiency.d. Write SOPs in accordance with the applicable responsibilities scope, and support the team SOPs writing.e. Support team trainings where appropriate.
- Others:a. Interface, as needed, with GRA/EMEA compliance & business support teamsb. Provide guidance to peers within J&J and other external partners on the applicable responsibilities scope.c. Report Adverse Event & product quality complaints as per J&J Pharmacovigilance guidelines.d. Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).QualificationsRole Requirements:Education & qualifications:
- Bachelor’s Degree
- Initial experience in Regulatory Affairs or QualityKnowledge & Abilities:
- Basic knowledge about Regulatory Affairs and Quality processes
- Experience in use of a selection of the following technologies: Information systems based on database technology or Web/Internet technology, document management systems
- Used to MS Office Suite, and effective knowledge of Excel
- Fluent in spoken and written EnglishSkills:
- Principles of validation and maintenance of compliance
- Ability to manage multiple assignments
- Ability to work cross
- Organizational skills
- Good communication and presentation skills, both verbal and writtenPersonal Qualities:
- Results and Performance Driven
- Analytical Thinking
- Concern for Order & Quality
- Flexibility/AdaptabilityPrimary Location:Europe/Middle East/Africa-Lebanon-Beirut-BeirutOrganization: 99999 Johnson & Johnson Middle East FZ LLC (Lebanon Branch)Job Function: Regulatory Affairs