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
職位要求
Please refer to job description.
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HR ManagerAmbica International Corporation
工作地址
#9 Amsterdam Ext., Merville Park Subdivision, Parañaque, Metro Manila, Philippines