Responsible for cGMP related issues, well-versed in deviation/investigation system internal and external audits and in quality oversight of contract manufacturers. Should have strong background in Quality Assurance Management, cGMP, GCP, ISO, GLP, QSR regulations and close out deviations. Skills in Track Wise. This position is directly responsible for ensuring that the Quality Investigations group functions in a timely, efficient and effective manner; and performs in compliance with current regulatory and company expectations.
Responsibilities include –
- Responsible to perform in-process and finished product inspections and document results on various packaging lines.
- Responsible to make sure packaging is done according to cGMP and customer/nutra-med specifications.
- Responsible to maintain, calibrate and inspect all testing equipment.
- Responsible to maintain the cleanliness of the area and take care of waste management.
- Perform end of the line cleaning and end of lot functions when lot is ended that is to count all remaining components and documents quantity in the batch records.
- Responsible to make sure all packaging personnel are properly trained for perform assigned packaging tasks.
- Responsible to pull customer samples, retain samples and any other samples requested by supervisor or customer.
- Responsible to review temperature and humidity requirements for packaging product and to make sure packaging is done within those ranges for temperature and humidity.
- Responsible to make sure lot# Exp.date and all components are verified and checked at start of the order and when ever components are issued on the line.
- Responsible to make sure packaging people on the line are properly wearing uniform and protective gloves, hairnet and beard cover as required.
- Responsible to make sure all packaging people are following safety procedures.
- Responsible for receiving, documenting, performing and approving incoming inspection of the finished product and components as per customer and making sure its compliance with the cGMP when required and in absence of incoming QA associate.