Qc Specialist

3 weeks ago

Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 66964**Job Type**
- Permanent**Job Title**
- QC Specialist (Deputy Responsible Pharmacist)**Computer Skills**
- Ms office Suite**Industry**
- Veterinary**City**
- Johannesburg**Province**
- Gauteng- JOB SUMMARY/PURPOSE:
- At local level, provide and ensure the quality oversight of activities in a defined scope (manufacturing, warehousing, and releasing of locally manufactured products registered under Act 36 of 1947).
- Perform QC checks and release of imported products registered under Act 36 of 1947 and Act 101 of 1965.
- Be responsible for Quality documentation, e.g., SOPs, Annual Product Reviews.
- At local level, conduct internal audits of the activities and manage projects as appropriate.
- Assist QA Manager as auditor for complex / external audits
- ACCOUNTABILITIES:
- Act as Deputy Responsible Pharmacist for the entity- At appropriate level of Quality & Strategy:
- Implement and improve the quality system
- Release non-GMP/GMP products and materials (including investigational products).
- Be accountable for quality-related decisions (depending on seniority level).
- Manage product-related deviation, change control and action plan processes.
- Complete assigned CAPA, change control or any other assigned actions according to target dates.
- Be responsible for pharmacovigilance (product complaints and adverse drug events).
- Be responsible for the stability program.
- QMS & documentation- Write QMS documents
- Approve SOPs in their area as applicable.
- Community Building and activation- Ensure continuous improvement in the production processes in conjunction with other departments locally.
- Build training modules and present Quality training sessions.
- Audits & Inspections- Assist with external audits as required (contract research sites, laboratories and manufacturers).
- Assist with internal audits as appropriate.
- Conduct self-inspections
- Possibly host inspections
- Main Activities / Responsibilities:
- 1. Validations and Calibrations- Ensures the annual calibration of equipment and systems.
- Ensure validation of equipment and processes.
- 2. Quality control for production- Assist with creation of COA‘s for local manufactured products, premixes and multivitamins.
- Take part in quality problem solving with batch failure.
- Assist with customer complaints (evaluate retention samples and re-analyse if necessary).
- Conduct line-opening and in-process checks in Production.
- Trending of analytical results for local manufactured products.
- Perform viscosity testing on manufactured products on request.
- Assist in manufacturing of pilot batches for stability testing.
- 3. Retention samples and sampling (vaccines, raw materials, finished product and animal premixes)- Ensure sampling is done on all raw materials, vaccines, animal premixes and finished product (if necessary)
- Ensure the composite sample (animal premixes) is sent to the correct laboratory, timeously. Ensure follow up with laboratory to expedite results.
- Ensure samples are recorded in the logbook and updated on Share Drive.
- Responsible for the retention sample area (vaccines, premixes, finished product and raw materials)
- Ensure retention samples are maintained under the correct conditions.
- Update the database sample location areas.
- Arrange the destruction of obsolete samples.
- 4. Quality check for Poultry- Check all receipted vaccines for compliance with cold chain requirements (checking the temperature of vaccines on receipt and upload loggers in the Cloud)
- Ensure inclusion of the correct package inserts for vaccine if necessary
- Check batch numbers and expiry dates according to Certificate of Analysis.
- 5.Audits- Conduct and assist with internal and external audits if necessary.
- Compile audit report.
- Follow up and implementation of the corrective actions.
- 6. Obsolete stock- Assist with re-testing where applicable.
- Assist with destruction where applicable.
- Ensure that rejected, returned, and quarantined stock is segregated.
- Assist in destruction of damaged and rejected labels.
- Assist with product recalls
- 7. Training- Assist with providing training for all personnel on SOPs and GMP/GWP in the production and warehouse departments- 8. Environmental Analysis- Ensure temperature(max-min) are monitored twice daily and out of specifications temperatures are recorded and reported to the QA Manager (fridges, warehouse, retention sample area and production).
- Ensure trending and review of temperature.
- Assist with temperature mapping of the warehouse.
- Assist with environmental controls (taking of swabs, agar plates)
- Perform sampling of the RO water system when required.
- Perform random check of the Magnehelix gauges in production and confirm pressures are in the required ranges.
- Assist with reporting and handling of spillages in warehouse.
- Download the temperatures (Escourt loggers) once a month.
- Report all out of specification readings on RO water plant (conductivity, pH) and air

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