Quality Assurance Pharmacist
3 weeks ago
The Quality Assurance Pharmacist will be responsible for ensuring that Company Products comply with local and international Quality Assurance Standards. This includes certifying legal compliance and ensuring the quality assurance function throughout the processes involved, including product release.
Key Responsibilities
• Spearhead the vendor selection process according to company SOPs
• Conduct vendor inspection audits in compliance with current Good Manufacturing Principles and Quality Assurance principles
• Assist with confirmation of implementation of Quality Technical Agreements
• Define quality improvements plans to support continuous improvements to the contractor quality systems
• Independently periodically assess the overall quality risk associated to the contractor
• Act on adverse trends to improve contractor quality compliance
• Assess product related change proposals from a quality and GMP perspective
• Support submissions of accepted changes through regulatory compliance
• Manage the timing of implementation of change at the contractor
• Independently evaluate the impact of the deviation to the quality of the product
• Where necessary initiate a deviation report to the responsible pharmacist and assist in any investigation and proposal of corrective and preventative action
• Manage the implementation of any proposed corrective action and provide feedback so that the deviation can be closed
• Assist with self-inspection audits and support the responsible pharmacist with Afrivet Business management audits by South African regulatory bodies with regard to GMP/ ISO:13485
• Where required in accordance with local regulations
• Ensure that the contract manufacturer is operating a Stability Surveillance program for Afrivet products in accordance with GMP requirements and that any Out of Specification (OOS) stability results are promptly handled and communicated
• Oversee manufacturer quality control, authorising pre-approved labels for printing, performing regular spot checks of incoming FPP to the warehouses for label compliance, fill volume and container compliance with registered specifications
• Contribute to the development and maintenance of SOPs
• Participate in technical/quality meetings to ensure GMP/GCP guidelines are adhered to
• Ensure a consistent approach to the interpretation and implementation of GxP standards of the animal health industry
• Support the process of documentation retrieval and collation to support product registration renewals
• Act as QA focal point for regulatory communications and changes
• Assist in the compilation of product Safety Data sheet
Requirements
• A degree in pharmacy
• At least 2 years' experience in QA/QC type roles supporting commercial pharmaceutical operations
• Registration with the South African Pharmacy Council
• Strong analytical thinking, problem solving skills, attention to details, shows strategic ability, leads change, honest and consistent, team player, high level of integrity in all customer and business related activities
• Willing to travel up to 20% for vendor audits
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