Aequor Information Technologies Pvt. Ltd. · 1 day ago
Compliance Specialist
Ridgefield, NJ
Contract
Onsite
Mid, Senior Level
$25/hr - $25/hr
3+ years expAequor Information Technologies Pvt. Ltd. is seeking a Compliance Specialist to support Manufacturing by investigating and managing non-conformance reports (NCRs) for production and environmental monitoring events. The role involves working with cross-functional teams to implement corrective and preventative actions and conducting effectiveness checks to ensure compliance with industry regulations.
ConsultingDigital MarketingInformation Technology
Hiring Manager
Anusha Barri
Responsibilities
Investigate both significant and non-significant NCRs for production and EM events
Analyze data and Identify the root causes to ensure a thorough investigation and identification of underlying issues
Write and maintain comprehensive Client reports, including all necessary details such as cause, impact, and actions taken
Work closely with cross-functional teams to develop and implement corrective and preventative actions in response to Client findings
Ensure CAPAs are well-defined, actionable, and address the root cause effectively
Monitor and track the progress of CAPAs, ensuring timely resolution and documentation of outcomes
Conduct effectiveness checks (ECs) to assess the success of implemented CAPAs and Client resolutions
Analyze the results of effectiveness checks to ensure that corrective actions have been effective in preventing recurrence
Recommend further adjustments to CAPAs if necessary, based on the effectiveness checks
It is required that individuals care for their own safety and wellbeing
Individuals must promote a safe working environment for employees and contractors working in their area of responsibility
The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations
Individuals must complete all required HSE trainings
Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility
Individuals must ensure timely closure of HSE actions owned by their departments
Qualification
Required
High School Diploma or GED and 8-10 years' experience preferred
Bachelor's Degree and 3-5 years' experience preferred
Proficiency in using Microsoft Excel and Word
2+ years of experience in manufacturing, quality assurance, or related fields, with experience in managing NCRs, CAPAs and ECs
Knowledge of industry regulations such as GMP, ISO 9001, and FDA guidelines
Strong analytical, problem-solving, and investigative skills
Excellent written and verbal communication skills
Proficient in Microsoft Office Suite and document control software
Company
Aequor Information Technologies Pvt. Ltd.
Aequor information technologies (P) limited is a part of US based IT MNC having more than 10 locations around the world with $ 100 M turnover.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase