Pharma Regulatory Officer

REF NUMBER**:FP041**

STATUS**: OPEN FOR APPLICATIONS**

PLEASE TAKE NOTE
- A copy of your CV
- Whatsapp number
- Copy of your ID,
- Copy of valid drivers license
- All qualifications (Matric and Tertiary Qualifications)
- A clear and recent head and shoulders image of yourself

**CV must include the following or will not be processed**:

- **Full CV (**FULL name and what you are known as**) **with all dates - e.g. Jan 2015 - Jul 2018 (not just year**)**:

- **Reasons for leaving each position**:

- High School & Tertiary Education must have the year completed **and the institution name**:

- Your current notice period (1 Calendar month or 30 days)
- Your current salary package including benefits (CTC)

JOB DETAILS

AREA: PRETORIA, GAUTENG

INDUSTRY: NUTRACEUTICALS/HEALTH

SALARY / CTC : R20 000 - R25 000

REPORTS TO: DIRECTOR

WILL BE AN ADVANTAGE IF YOU ARE AVAILABLE IMMEDIATELY

To ensure that the Company complies with the Quality principles as set out by legislation of the Medicines Control Council (MCC) and the South African Pharmacy Council (SAPC) and to ensure products released by the company onto the market meet all quality specifications.

ROLES AND RESPONSIBILITIES
- GMP/GWP/GDP compliance
- Accurate record keeping
- Self-inspections
- SOP compliance and review
- Manufacturer/packer/lab audits
- Technical agreement compilation, review and updates
- Distribution of agreements
- Investigation of technical complaints and trend analysis
- Annual product reviews (SOP, plan and review)
- Ensuring validity of customers and SOP update
- Disposal of expired or rejected stock and retention of stock destruction certificates.
- Customer QC Control on finance new accounts opened
- Product sampling for re-testing
- Facilitate post importation testing
- Oversee standard levels at laboratory
- Batch documentation auditing, record and control
- Finished product release
- Ensure quality of products out in the market
- Storage and control of retention samples
- Submission of status reports
- Artwork/packaging review and approval
- To review and approve the validation reports
- Development control and approval of new product bar codes
- To review and approve master documentation
- Stability test results
- Managing schedule 6 registers
- Implementation and monitoring temperature on incoming shipments
- Documentation management and control
- Validation of stock control system to control authorised product release and automatic quarantine and release of stock
- Mock recall
- Quality Manual
- Risk Management
- SOP Review and updates
- Keep informed of changes in Regulations or legislative changes that will impact on the way Austell manages its quality systems
- Ensuring that quality systems are in place and are continuously updated to reflect current practice
- Ensuring that all information is readily available for audit purposes and that it is backed up

REQUIRED QUALIFICATIONS, SKILLS AND EXPERIENCE:

- Minimum 2 year’s experience as a QA Officer
- Intermediate understanding of Microsoft Office (Excel, Word, Power point and Outlook).
- Updated knowledge of MCC and SAPC legislation and guidelines
- Updated knowledge of pharmaceutical GMP/GWP/GDP/GLP

**Salary**: R20,000.00 - R25,000.00 per month

Ability to commute/relocate:

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

Application Question(s):

- Do you have a Minimum 2 year’s experience as a QA Officer
- Do you have Updated knowledge of MCC and SAPC legislation and guidelines
- Do you have Updated knowledge of pharmaceutical GMP/GWP/GDP/GLP