Overview
To perform pharmaceutical functions within the Release sub-department of the QA department. This involves review and release of products according to GxP and company Standard Operating Procedures.
Responsibilities
General Operational Activities
Execute daily tasks and work instructions according to the relevant SOP's.
Update and maintain databases
Generate reports as per instruction
Verify and interpret the accuracy of data and audit documentation
Ensure that all relevant documentation gains the necessary signatures for completion
Maintain accurate filing and retrieval of documentation
Perform any other administrative tasks relating to your work as and when required
Product Quality Reviews
Compiling PQR schedule based on risk assessment.
When required, compile PQR reports based on raw data provided by the manufacturer.
Review PQR reports compiled by Admin Co-ordinator or Pharmacist Assistant for accuracy and compliance to dossier, Technical Agreement and GMP requirements.
Reviewing PQR reports provided by manufacturer for accuracy, compliance to dossier, Technical Agreement and GMP.
Identifying risks arising from PQR reviews, escalating to management and performing risk assessments where required.
Ensure that appropriate CAPA’s are identified from PQR reviews, and the relevant department is notified to implement and ensure Effectiveness check is performed,
Propose and developed methods for improving PQR’s.
Reporting And Quality Systems
Compiling of Monthly Departmental Report
Compiling AD-hoc reports as required
Compiling and reviewing of SOP’s related to work function, i.e. PQR’s.
Perform training on the relevant SOP’s related to work functions, where required.
RECALLS, BLOCKED STOCK REPORTS
Manage recalls, collation of information, and communication to the relevant involved parties.
Manage Blocked stock Situations
Conduct Mock recalls as per schedule and SOP
Log and manage required actions/ records in electronic QMS
Human Resources
Compliance to Labour Legislations and In-house Best Practice)
Familiarise yourself with and at all times act in accordance with the company policies and procedures
GMP Compliance
Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities.
Ensure that products are handled according to the required SOP’s and documentation.
Health, Safety And Environmental Standards
Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
Report any unsafe or unhealthy situations to SHE representative or Line Manager
Report any incident to the SHE representative or Line Manager which may affect your health or cause injury
Skills Required
Background/experience
Matric/Grade 12
Bachelor in Pharmacy
Registration with South African Pharmacy Council (SAPC)
Computer Literate – MS Word & Excel
Specific job skills
Strong working knowledge of pharmaceutical manufacturing
Sound knowledge of Good Manufacturing Practice
Pharmaceutical standards and compliance requirements
People management
Ability to interpret and implement policies, processes and objectives
Good Documentation Practices
Competencies
Interrogating Information
Managing Performance
Planning and Organising
Finalising Outputs
Customer service
