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Regulatory Affairs Pharmacist

2 weeks ago

Paranaque City, Calabarzon, Philippines Ambica International Corporation. Full time

Job Description

Responsible for verifying the activities done during the In-house inspection of finished products and ensuring FDA requirements and company objectives are met.

  • Monitors compliance of all staff with the requirements of GMP
  • Ensures that the products comply with the specifications as per approved artwork or finished product specifications
  • Signs Batch Inspection Records after every activity is done
  • Counterchecks damages and non-conformances
  • Ensures that the products are inspected and stored accordingly, to obtain the required quality
  • Ensures strict implementation of instructions (SOPs) to QC procedures.
  • Makes new SOPs, revises or updates existing SOPs
  • Performs activities related to Pharmaceutical Quality System (such as Product Quality Review, Quality Risk Management, Change Control, Deviations, OOS and CAPA)
  • Ensures initial and continuing training of QC staff is carried out and adapted according to need
  • Ensures communication with the concerned departments to raise quality issues to the appropriate levels of management
  • Coordinates with the Production, Warehouse, Sales, and Regulatory Departments regarding quality issues
  • Generates inspection reports, or other reports, as needed
  • Ensures that all measuring and monitoring devices (weighing balances, thermohydrometers, data loggers, bio ref, thermal gun, etc.) used by the company are calibrated; ensures proper coordination with other concerned departments (ex. Production and Warehouse) regarding calibration schedules and maintains an updated calibration master plan as needed
  • Performs and/or supervises daily and monthly internal calibration of weighing balances in the Production/QC Area
  • Other responsibilities that are deemed necessary by the Management

Job Qualification

  • A Licensed Pharmacist with active license
  • Knows how to operate Microsoft Office Applications
  • Knowledge of the Good Manufacturing Practices and FDA guidelines
  • Highly self-motivated, goal-oriented, and committed to pursuing a long-term career
  • Can work under minimal supervision