Regulatory Affairs Associate
Arnet Pharmaceutical Corp
Date: 9 hours ago
City: Davie, FL
Contract type: Full time
Essential Functions And Responsibilities
- Responsible for developing, generating or editing controlled documents such as: Standard Operating Procedures ,SOP related Forms, raw materials and finished product specifications, methods for testing, validation reports, complaints, certificate of analysis templates, protocols, deviations, laboratory notebooks and Product monographs
- Responsible for the revision of Master Formulas upon creation/revision
- Responsible for control and distribution of SOPs (new and revisions)
- Coordinates change control system and compliance
- Prepares annual and refresher training material as per Training Matrix and coordinates annual GMP training.
- Coordinates audit schedules for Vendor Qualification purposes.
- Generates supplier audit reports and follow ups.
- Handles Customer and regulatory audits as required by the Director of Quality or President.
- Responsible for generating CAPA reports to customer audits.
- Prepares regulatory documentation for submissions as required.
- Responsibilities include document review to ensure accuracy, secure storage, efficient access to technical documentation for review or updating and maintenance of Documentation files/databases to ensure data accuracy
- Monitors processing status, location, secure hard copy master files, document searches, copies and archival
- Coordinates adherence to cGMPs and company SOPs, policies and records with area supervisors.
- Perform other duties as assigned by the immediate Supervisor.
- Bachelor’s degree in Science or equivalent work experience or a combination of both.
- 1 - 3 years’ experience
- Bilingual (English and Spanish) preferred
- Knowledge in GMP regulations
- Computer literate
- Detailed oriented
- Previous experience working in production or QC preferred
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