J&J Family of Companies Quality Assurance Pharmacist in Johannesburg, South Africa
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 / Cluster1. 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
- 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
- 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
Initiate Quality Investigations on Trackwise
Investigate root cause and evaluate deviations, implement CAPAs and conduct Effectiveness checks if necessary
- Change Control
Initiate Change Controls on Trackwise
Ensure implementation activities are documented and completed on time
Prepare QSMR report and presentation, detailing key activities and metrics in the QA department as per SOP requirement
Annual Product Review
Review Product Quality Review reports from manufactures and compile summary reports
Correct filing of all Product Quality Reviews/ Annual Product Reviews
- Audit Management
Management and execution of internal audits
Management and execution of external and supplier audits
- 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.
- 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.
- 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
- 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
- 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
- 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
Ensure the provision of appropriate training for all regulated functions with GMP/GDP responsibilities.
Ensure suppliers in the LOC / Cluster are qualified, have a quality agreement and are periodically audited against company & local GMP standards, if relevant.
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.
Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in South Africa are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
When appointing potential candidates in South Africa, the Employment Equity and Broad-Based Black Economic Empowerment Legislation will be considered.
Essential Knowledge and Skills:
Minimum 2 years’ experience in Quality Assurance, Production, Distribution or Pharmaceutical Industry
Core Competencies Required for This Role:
Up-to-date knowledge of relevant local pharmaceutical legislation and GMP/GDP/GLP
Stock analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners
Knowledge and full understanding of the J&J Quality Management System Policy (POL-001), the Commercial Quality standard operating procedures and the Quality Manual
Janssen Pharmaceutica (Pty.) Ltd. (8490)
J&J Family of Companies
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