My client is a Pharmaceutical company who seeks to employ a Quality Assistant

Minimum Requirements:

5 - 6 Years Experience as a Quality Assistant within a Pharmaceutical company.
Tertiary Education will be an added advantage

Role

Compiling and systematic filing of all Quality Related correspondence and MCC correspondence
• Maintenance and up keeping of Master Documentation,
• Performing generation of final release documentation of all registered products
• Generation of scheduling for review of SOP’s, Audits, and timeously tracking of all Quality related procedures and processes
• Managing change control documentation for all products, processes and procedures
• Liaising with relevant managers in regard to SOP’s
• Ensuring promotional material is in accordance with legal requirements
• Handling all incoming medical queries and diverting to relevant persons
• Handling all paperwork for customer complaints
• Ensuring printed packaging materials comply with legal requirements
• Summation of stability reports
• Summation of all APR’s ,OOS's,OOT's, PQR’s and Deviations from 3rd party contractors
• Maintenance of all registers of retention samples
• Maintenance of all log books
• Preparation of documentation for Self Audits
• Preparation of Training documentation and maintaining all GMP training personnel logs
• Preparation for weekly agenda’s with Emerging Markets Quality personnel
• Maintenance of a tracking system for all Quality related processes, issues and concerns

• Developing quality systems improvement initiatives
• Managing the ongoing improvements to comply with all regulatory bodies
• Maintaining a relationship with local (MCC) and international regulatory bodies
• Assist in identifying specific requirements for new product launches
• Performing technical assessments/ audits of partner laboratories, warehouses and packaging facilities
• GAP Analysis of processes and procedures
• Risk Analysis Assessments and Reports and CAPA’s
• Handling a medicine recall in accordance with MCC requirements
• Reviewing and implementing quality control and quality assurance procedures
• Reviewing and updating Technical Agreements with all third party contractors
• Training appropriate personnel in SOP’s and other relevant areas
• Regular auditing suppliers and third party contractors
• Negotiating and facilitate the development of Quality Agreements
• Ensuring skills of the staff are continuously updated and versatility is developed by all appropriate means.
• Partnerships in compliance with company and regulatory requirements