QUALITY ASSURANCE OFFICERS

Monitoring compliance with cGMP

requirements by inspecting all manufacturing areas, Equipment and systems daily,

to ensure that they comply with cGMP in all aspects of suitability of

manufacturing medicines.

Monitor and ensure that there is

proper and correct documentation of all production activities and that records are updated online.

Review BMRs online to verify that

all production stages have been completed in accordance with SOPs and all

signatures and dates of persons performing and checking activities are in

place.

Monitoring and controlling of the manufacturing environment, including housekeeping practices, which include personal hygiene and cleanliness of manufacturing premises.

Prepare Qualification Protocols,

Perform Equipment Qualification (DQ/IQ/OQ/PQ/RQ) and approve or reject

equipment/ machinery based on qualification

processes.

Prepare Process Validation

Protocols, perform Process Validation, and approve or reject processes based on Process

Validation Reports.

Carrying out In-process Quality

Control Checks like friability, uniformity of mass, disintegration tests, moisture

content, hardness, and thickness tests of all products.

Monitoring and ensuring that the

environmental conditions like temperature, pressure and relative humidity

are within specifications, hence don’t affect the quality of the products.

Reviewing

completed Batching Manufacturing Records: This includes In-process Quality control records and laboratory

batch testing records for completeness.

Identifying and investigating deviations in manufacturing processes.

Document control and record

keeping: This includes filing, archiving, and maintaining a robust

documentation system for all GMP documents.

Writing and maintaining SOPs: This includes

writing and maintaining standard operating procedures (SOPs) for the QA

department and other departments.

Preparation, Issuance, and Distribution

of Controlled Documents: This includes issuing, stamping,

and distributing controlled documents, such as approved procedures,

specifications, and protocols.

Preparing manufacturing records: This includes

preparing batch manufacturing records (BMRs) and batch packaging records

(BPRs) for production. It also involves the issuance of different Products

batches' manufacturing records from the master batch records according to

the production plan, allocating unique numbers and handing them over to the production department.

How to Apply:

All applications will be received and reviewed through the BrighterMonday Portal by clicking on the 'Apply Here' section

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