Commercial Quality Senior Specialist

2 days ago

Johannesburg, South Africa Johnson & Johnson Full time

**"Caring for the worldone person at a time” **inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

**The Commercial Quality Senior Specialist is responsible for performing Quality Assurance activities in the Commercial Quality Department.**

The Commercial Quality Senior Specialist is responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC/ Cluster (including all named-patient materials NPP / SPR process (what are, product samples).

He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP/GDP activities the LOC / Cluster undertakes. This position is also responsible for the continuous improvement of the GMP / GDP status of the LOC / Cluster.

He/she is responsible for the oversight of quality and compliance status of all third parties and other J&J organizations engaged by the LOC / Cluster for the GMP / GDP activities for the LOC/ Cluster.

**Implement, maintain, and monitor the GMP/GDP part of the J&J quality system for commercial organisations in the LOC / Cluster**

**1. Responsible for the Release of Finished product**:

- Review and release batch documents and Final Product Release Forms from Third Party Manufacturers procedure
- Sign off of Finished Product Release Forms from Third Party Distributors as per procedure
- Coordinating sampling and testing of imported finished products between Third Party Distributors and Third-Party Laboratories
- Following-up on release and liaise with Supply Chain Manager with regards to out of stocks
- Correct filling of all release documentation
- Management of Retention Stock

**2. Process all QA Complaints**
- Recording of all QA customer complaints
- Coordinating the replacement of product and upliftment of complaint samples
- Ensure input of relevant complaints into global database
- Processing and assessment of QA customer complaints
- Identifying all QA customer complaints that require immediate action ie Escalation or Recall as per procedure
- Reconciling all QA customer complains on weekly basis together with Pharmacovigilance and Medical Information departments
- Ensure all complaints of products that are manufactured by the third-party manufacture are reported to and investigated by the third-party manufacturer

**3. Control Substance Management**
- Ensure activities are carried out in compliance with the specific requirements applicable to controlled substances.
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances
- Applications for Narcotic Export and Import Licenses for Exportation and importation of stock in South Africa
- Coordination of Narcotic Export Licenses between Janssen and Distributors/Supply Chain
- Export and Import Permit Triplicate Return to Department of Health
- Filling and retrieval of Narcotic Export and Import Permit documentation
- Compilation of annual returns for HA submission

**4. Deviations**
- Initiate Quality Investigations on Trackwise
- Investigate root cause and evaluate deviations, implement CAPAs and conduct Effectiveness checks if necessary

**5. Change Control**
- Initiate Change Controls on Trackwise
- Ensure implementation activities are documented and completed on time

**6. Prepare QSMR report and presentation, detailing key activities and metrics in the QA department as per SOP requirement**

**7. Annual Product Review**
- Review Product Quality Review reports from manufactures and compile summary reports
- Correct filing of all Product Quality Reviews/ Annual Product Reviews

**8. Audit Management**
- Management and execution of internal audits
- Management and execution of external and supplier audits

**9. QA Project/Activities**
- Carry out Quality Assurance Projects related to External Manufactures and Distributors and/or any Janssen QA activities including involvement in EMEA Quality Projects.
- Attend monthly meetings to discuss quality issues and contribution to quality projects.

**10. Act as a Backup**
- Back up support for all other QA functions for Quality Assurance department
- QL approver for quality related activities.
- Review and approval of quality related activities and records as Quality Approver for LOC, 3PL and or Distributors.

**11. Compliance Matters**
- Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately mana

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