QA Assistant

Division

CMM

Department

Quality

Employment Type

Permanent

Job Purpose

QA Assistant is responsible for clerical and administrative duties related to the QA office, including but not limited to capturing of finished product results onto certificate of analysis, scanning of documents to customers, and maintaining the finished goods retention store.

Other functions include, printing and issuance of documents, issuance, archiving and destruction of Logbooks and batch documents

Accountabilities

Maintenance of the retention stores by logging of retention samples and pulling out samples for destruction as well as environmental monitoring daily. Preparation of Certificate of Analysis for product release.

Scanning of standard documents for third party batch release requirements and e-mailing to respective parties.

Electronic filing of release document sets on CMM network.

Destroying of expired retention samples/documents as per agreed timelines.

Sending all documentation required for batch releases and attend to customer queries.

Involvement in investigation of deviations / root causes analysis.

Creation and application of release labels for intermediates and finished product where required on site and for all palletized stock prior to dispatch. Requisition and collation of additional release documents as required for by third party applicants such as API COA from QC laboratory

Prepares and issues logbooks to users.

Retrieves, archives and destroys logbooks as required. Maintains an effective logbook register.

Replenish paper and consumables for photocopier General administrative and clerical duties including but not limited to general filling, typing as required, photocopying, faxing, emailing, ordering of consumables.

Accountabilities 2

Assist with preparation of destruction list for documents due for destruction.

Shredding of documents that are due for destruction as required

Assist with document archiving and destruction in the QA document retention store

Assist with making Authorized, Training and Uncontrolled SOP copies when required

Creation and modifying electronic and / or hard copy documents as requested.

Maintenance of QA related documentation and records.

Checking of Batch documents prior to issuance for correctness.

Support QA staff in assigned project work.

Ensure compliance with statutory requirements and requirements of Good Manufacturing Practice and cGMP

Education Qualification

Matric

Pharmacist assistant basic/Post basic

Tertiary related qualification will be an added advantage

Relevant Work Experience

Minimum 2 years' experience in a pharmaceutical environment

2 years clerical/administration experience

Job Location

Mobeni , Durban