Quality Assurance Pharmacist - Kempton Park Verfied

Salary Negotiable Kempton Park, Gauteng Kempton Park, Gauteng more than 14 days ago 10-02-2016 12:59:49 PM
09-03-2016 12:59:49 PM
My client is a Global company who seeks to employ a QA Pharmacist.

Minimum Requirements:

Bachelor of Pharmacy
Knowledge of GMP/ HACCP/ Food safety . SHE
2-3 Years experience in Pharma production environment
SAPC registered
Experience in quality related systems
Quality Assurance experience in a technical job

Role

? Preparation of stability review reports
? Preparation of stability data sheets for submission to regulatory authorities
? Input ideas and technical data for new product and packaging developments
? Preparation and submission of stability samples for testing to QC and Micro Labs
? Development of SOP’s
? Editing and control of SOP’s
? Preparation of internal audit schedule and conducting internal audits
? Back up for conducting QA Releases in the absence of QA Manager
? Maintenance of regulatory data base and ensure compliance to current regulations
? Approval of all artwork i.e. package inserts , labels , shrinks etc.
? Preparation of scientific and legal documents as per the request of the customer
? Preparation of dossiers for submission to regulatory authorities in CTD Format for both the local and international markets
? Planning of product trials and regulatory inspections
? External audits of suppliers on request by management
? Attendance of regulatory meetings / workshops on request of management and thereafter training other staff on the regulatory requirements as required
? Creation of raw material worksheets on SAP
? Preparation of meeting minutes for food safety team and food safety management meetings
? Approval and sign off for all third party documents
? Approval of packaging documents on site.
? Development Pharma cGMP system: SOP’s, Batch records, Release specification, VMP, SMF, Quality Manual etc.