QA Document Controller

2 weeks ago

Midrand, South Africa Triton Pharmaceuticals Full time

1.1 QA Department Document Control, which include the safe keeping and issuance of, production documents, deviations and change controls.

1.2 Manage the Master Production documents and SOPs, i.e., ensuring limited access to the Documents.

1.3 Create all necessary all SOPs for Procurement, Receiving, Dispensary, Manufacturing, Packing, Dispatch production with the aid of the department supervisor.

**2* **RESPONSIBILITIES*

**2.1. KEY RESULT AREAS**:
**2.1.1 Documentation**
- Good housekeeping throughout areas of responsibility.
- Ensure all production documents are valid and updated.
- Ensure all stock codes have been entered in correctly on the documents.
- Ensure all spelling of the individual items are correct and match with the system
- Work with the team leaders and supervisors to confirm that the process is correct and if not update.
- Ensure the reviewed document are completed and handed for signature
- Ensure that all the SOP's on the list are updated before their update date.
- Ensure that when updating the SOP's that the supervisor and operator go through the process and update the procedure so that it is current and GMP compliant.
- Visit the facility and find areas where there are no SOP's and draw up the SOP.
- Take current SOP’s and test them. If the process is missing steps in the SOP, then update the SOP.
- Filing deviation reports, customer complaints reports, change control forms and registers.
- Mastering and Superseding documents/SOP’s
- Distribute SOP’s and Documents for signing, also distribute SOPs to people on the Distribution Lists of SOPs
- Typing of reviewed SOP’s.
- Typing of new and reviewed packing documents
- Distribute data loggers and cleaning log sheet monthly.
- Issuing and filing of all cleaning log books and Pest control sighting sheets.
- Make copies and launch documents for production when required.

**2.1.2 Trainer**
- Training and coordinating the training of new and existing employees, and maintaining register thereof.
- Ensure the training schedule is adhered to at all times.
- Ensure the training matrix is completed with the assistance of the supervisors and that all training is done according to the matrix.
- Coordinate and Conduct Training on SOPs and ensure staff from the Maintenance, Receiving, Manufacturing, Packing and Filling departments are trained timeously.
- Ensure all training records are handed to the correct department and that copies are filed per employee and easily retrievable.

**2.1.3 Other Areas of responsibility**
- Participate in preparation and carrying out of GMP internal/external audits.
- Assist QA Manager when assigned.
- Preparing of Documents and Samples for sending to customers.
- Maintain a register of the cleaning chemicals and order the cleaning chemicals to maintain stock
- Assist in downloading and storing all data on the temperature and humidity data loggers

**Salary**: From R6,000.00 per month

Ability to commute/relocate:

- Midrand, Gauteng: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Diploma (preferred)

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