Quality Assurance Auditor (Temp)

The incumbent will be required to ensure integrity in the maintenance of Bryden pi Ltd.’s QMS and promote adherence to established procedures, standards and specifications for the Company’s processes, products and services.

Some Main Responsibilities include: 

Periodic audit of bin integrity checks, manual adjustments for Antibiotics and Controlled Drugs and product setup on VAI against Supplier Info.

Prepare report of all variances for items checked.

Track non-conforming goods from point of identification, tag, segregate, verify, write-off, claim and co-ordinate with Regulatory Team to destroy.

Weekly inspection and reporting on contents of non-conforming bins.

Follow-up with appropriate personnel to process non-conforming goods out of the bins.

Assist Regulatory Team in sorting non-conforming products by Supplier.

Trace recalled products from point of receipt at warehouse, tag, segregate, reconcile with VAI quantities and liaise with appropriate departments for return to supplier or destruction.

Assist Regulatory Dept. with product destruction.

Disassemble coolers – replace icepacks to freezer/chiller on a daily basis and rotate gel/icepacks to ensure recommended chilling/freezing time is achieved.

Download or clear data from data loggers.

Replace data loggers in chiller after use and audit settings periodically

Track and monitor temperature monitoring devices by location.

Assist in qualification and validation exercises for coolers and temperature controlled rooms/storage spaces.

Perform internal and third party provider audits

Perform other duties that may be required to enhance the operations of the Company.

Qualification, Experience and Requirement: 

Professional certification in quality assurance/internal quality audits/TQM and/or knowledge of ISO 9001; 2015, WHO Technical Report Series and GxP Guidelines

Associate’s Degree in Business Administration or equivalent

A minimum of two (2) years’ experience in a similar capacity.

Knowledge in WMS S2K will be an asset.

Or relevant combination of training and experience

Must provide a valid Police Certificate of Good Character

Key Competencies:

Good interpersonal, communication and analytical skills

Good organizational and solution-oriented skills

Must be a self-starter, flexible, honest and reliable