Quality Assurance Pharmacist at Johnson & Johnson

Job Description

Overall Purpose of the Job:

The Quality Assurance Pharmacist is responsible for performing Quality Assurance activities in the Commercial Quality Department.

The Quality Assurance Pharmacist 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 organisations engaged by the LOC / Cluster for the GMP / GDP activities for the LOC/ Cluster.

Essential duties and responsibilities:

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 managed when planning projects, developing materials, executing projects and contracting vendors

• Ensuring HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors

• Ensuring inspection readiness with respect to personal training compliance, and availability of a recent CV and individualized Job Description

12.   Third Party Logistic (3PL) / Third Party Manufacturers (3PM)

• Oversight and management of 3PL and 3PM  processes

• Ensure that 3PM and 3PL deviations are processed accordingly.

• Manage 3PL/3PM queries timeously, ensuring correct quality processes are followed.

• Ensure and drive green metrics, for 3PL/3PM quality processes, including releases, that feeds into Janssen Metrices to ensure no delays, and Janssen maintains a GREEN/GREEN Status.

• Raise queries or concerns with regard to 3PL/3PM for monthly/quarterly meetings.

• Ensure that required information is provided to 3PM and External Quality for PQCs investigations

13.   Post Importation Testing

• Track all requests to Third Party Labs

• Support Regulatory with product quality portfolio for PITE

• Request for Methods, Specifications and reference standard samples in support of local testing for PIT

• Support with HA documentation needed to import of samples

• Ensure that internal processes are aligned with HA guidelines including release process

14.  Escalation of Quality and Regulatory Compliance Issues

• Reporting, documentation and management of potential significant quality and regulatory compliance issues.

• Coordinate and oversee the escalation management process

15.  Ensure the provision of appropriate training for all regulated functions with GMP/GDP responsibilities.

16. Ensure suppliers in the LOC / Cluster are qualified, have a quality agreement and are periodically audited against company & local GMP standards, if relevant.

17. Collaborate effectively with various internal and external partners, such as the local Health Authorities, Regulatory, Supply Chain, the LSO, the manufacturing plant QA, CLS QA, the logistic department, other Cluster / LOC in EMEA and any other functions.

18. Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.