Regulatory Affairs Associate Job at Arnet Pharmaceutical Corp, Davie, FL

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  • Arnet Pharmaceutical Corp
  • Davie, FL

Job Description

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

Job Tags

Work experience placement, Immediate start,

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