Reg Affairs Associate

Reg Affairs Associate

ARNET PHARMACEUTICALS CORP - 3.0

Davie, FL Job Details Full-time 1 day ago Qualifications Quality control corrective actions Computer operation Spanish Document review (document control) Audit report preparation Procedural guides Technical documentation Audit engagement planning Computer literacy Content editing Corrective and preventive actions (CAPA) English Training material drafting Mid-level Manufacturing standard operating procedures Supplier audits Supplier audit compliance assessment Quality assurance audits Bachelor's degree Technical writing Document archiving Regulatory submissions Computer skills 1 year Regulatory compliance management

Full Job Description 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.

Qualifications:

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