QA Pharmacist, Pharmaceutical Company - Johannesburg, Gauteng
Glasshouse Recruiting
Nơi làm việc
Johannesburg
Hình thức tuyển dụng
Toàn thời gian
Chi tiết công việc
Introduction
Requirements:
Education & Skill / Experience Requirements:
• BPharm Degree
• Minimum 2 years’ experience as a QA Pharmacist
Skills / Physical Competencies:
• Intermediate understanding of Microsoft Office (Excel, Word, Power point and Outlook)
• Updated knowledge of MCC and SAPC legislation and guidelines
• Updated knowledge of pharmaceutical GMP / GWP / GDP / GLP
Behavioural Qualities:
• High integrity and honesty and are bound by ethical principles
• Resilient, does not give up in the face of setbacks
• Attention to detail
• Accuracy
• Analytical
• Time management skills
• Good communication skills
• Deadline driven
• Ability to resolve conflict
• Team player
• Good problem-solving skills
• Persistence
• Good organisational skills
• Good planning skills
• Good follow-up skills
• Assertive
The main purpose of this position:
To ensure that the Company complies with the Quality principles as set out by legislation of the Medicines Control Council (MCC) and the South African Pharmacy Council (SAPC)
To ensure products released by Client onto the market meet all quality specifications
Duties & Responsibilities:
• Providing ad hoc support to other departments when required
Responsible for compliance with legislation in terms of:
• GMP / GWP / GDP compliance
• Accurate record keeping
• Self-inspections
• SOP compliance and review
• Manufacturer / packer / lab audits
• Technical agreement compilation, review and updates
• Distribution of agreements
• Investigation of technical complaints and trend analysis
• Annual product reviews (SOP, plan and review)
• Ensuring validity of customers and SOP update
• Disposal of expired or rejected stock and retention of the stock destruction certificates
• Customer QC Control on finance new accounts opened
• Regulatory applications including SAHPRA, DOH, SAPC
Manages the Quality Standards with regard to:
• Product sampling for re-testing
• Facilitate post importation testing
• Oversee standard levels at laboratory
• Batch documentation auditing, record and control
• Finished product release
• Ensure quality of products out in the market
• Storage and control of retention samples
• Submission of status reports
• Artwork/packaging review and approval
• To review and approve the validation reports
• Development control and approval of new product bar codes
• To review and approve master documentation
• Stability test results
• Managing schedule 6 registers
Responsible for system implementation:
• Implementation and monitoring temperature on incoming shipments
• Documentation management and control
• Validation of stock control system to control authorised product release and automatic quarantine and release of stock
• Mock recall
• Quality Manual
• Risk Management
• SOP Review and updates
• Keep informed of changes in Regulations or legislative changes that will impact on the way the Client manages its quality systems
• Ensuring that quality systems are in place and are continuously updated to reflect current practice
• Ensuring that all information is readily available for audit purposes and that it is backed up
