SOW - Business Analysis Coordination
Posted on Feb 7, 2020 by NextLink Solutions
Job title: Business Analysis Coordination
Work location: Val de Reuil, France
Contract Dates: 17/02/2020 to 17/08/2020
Johnson & Johnson Consumer Products, a member of Johnson & Johnson's Family of Consumer Companies, is looking for an Analytical contractor to be located in Val-de-Reuil, France.
This contractor will work within the Life Cycle Management analytical section and support marketed OTC products primarily within the EMEA/APAC regions. A close collaboration with internal and external manufacturers, CROs, the GTO formulation development and the GTO deployment organisation will be important
General Job Scope:
To provide desktop support mainly for analytical compliance gap assessments but also for analytical test method development, method validation and quality control activities for a series of product transfers.
Quality and Technical desktop support would include but not be limited to:
Perform analytical compliance gap assessment versus current guidelines
Manage multiple CROs and other external partners simultaneously
Support analytical test method transfers
Support analytical test method troubleshooting
Support or initiate analytical test method improvement and validation
Manage change control deliverables and CAPA activities relating to analytical remediation
Educational - Minimum of a Master's degree with a major in chemistry or related sciences.
Work Experience and personal characteristics required:
A minimum of 5 years in an analytical laboratory role supporting pharmaceutical manufacturing, product development or quality assurance with a major emphasis on analytical method development, optimization, validation, verification, transfer and product testing. Experience with multi-ingredient liquid and solid-dose formulations essential
Experience and deep knowledge with HPLC/UPLC, GC, dissolution and other major analytical techniques
You need to be an innovative and a creative problem solver who can work independently, while managing multiple priorities successfully. The ability to influence others without direct line authority is highly preferred. You need to have both a team spirit and leadership skills. Strong written and oral communication skills are highly valued. Experience from working in a Matrix organization is desirable.
Comprehensive understanding of quality and regulatory compliance knowledge, pharmacopeia including USP, EP, ICH/WHO guidelines and good understanding of GxP systems
Technical writing and documentation review abilities