Business Systems Analyst Sr Job in Framingham, Massachusetts Us
Business Systems Analyst Sr
Description
Description
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Position SummaryProvide compliance support for the global quality systems including TrackWise, Plateau, LiveLink, Indysoft, CatsWeb, Legacy (Filemaker Pro and Access) Databases and reporting features (e.g. Crystal Reports) utilized by those Databases.
Core Responsibilities Establish compliance requirements and time frames when implementing changes or incorporating new systems.
Complete analysis, identify issues and provide recommendations for compliance improvements.
Perform review of results to audit process or equipment compliance to FDA and GxP requirements.
Provide guidance to less experienced staff.
Demonstrate understanding of 21 CFR Part 11and Annex 11 regulatory requirements.
Demonstrate understanding of Good Automated Manufacturing Processes (GAMP) 5.
Interact with project teams and research groups as they impact the quality operation.
Directly provide guidance to employees to ensure compliance to GxPs.
Help to remediate processes and systems in accordance with company standards and regulatory requirements.
Assist staff personnel in performing Risk Assessments based on system changes and/or implementation.
Additional Responsibilities May be responsible for Change Management and Software Development Life Cycle (SDLC). This requires a clear understanding of GAMP 5, Annex 11 and ASTM E2500.
May be responsible for compliance project management. Interpret complex, explicit documentation for new and current compliance procedures and FDA enforcement action/trends.
May be responsible for ensuring all Software Development Life Cycle (SDLC) documents exist and are maintained for the Quality organization in accordance with internal and external regulations, policies, and procedures.
Provide guidance to End User for their SOPs.
Participate in validation activities
Qualifications
Ability to independently determine Computer System Change management requirements with an emphasis on Software Development Life Cycle (SDLC), GAMP 5 and ASTM E2500.
Problem-solve independently.
Strong and effective organizational skills.
Motivate others who have other reporting structures.
Create and deliver effective presentations.
Lead and facilitate meetings/workshops.
Facilitate formal Risk Assessment.
AS or BS in Computer Science or Technology.
