Description:
Position: Quality Assurance Pharmacist
Location: Pretoria
Salary: Market-related
Job Purpose:
We are seeking experienced and detail-oriented Quality Assurance Pharmacists to join our team. The successful candidates will be responsible for ensuring strict adherence to the Quality Management System (QMS), current Good Manufacturing Practices (cGMP), and ISO 9001 standards.
Key Responsibilities:
Product Release:
Authorize product releases and verify records. Oversee the quarantine, sampling, and release process for saleable products. Review and approve packaging materials, raw materials, intermediate products, and finished goods. Inspect retention samples as representative batch samples. Recommend product recalls when specifications are not met. Control the issuing of labels and controlled printed materials. Serve as a member of the Change Control Committee.QMS Principles:
Implement and guide adherence to QA GMP and ISO principles. Ensure compliance with cGMP requirements, SOPs, and corporate procedures. Prepare, update, review, and approve quality-related procedures. Provide training on cGMP, SOPs, and relevant topics. Maintain and ensure compliance with quality agreements. Lead or participate in risk assessments and validation activities.Product and Process Performance:
Coordinate and control the stability program. Perform annual product reviews and trend analyses. Compile monthly and quarterly reports. Administer the Continual Improvement System and lead CAPA or deviation investigations. Establish product specifications.Audits and Projects:
Conduct supplier and internal audits. Prepare for audits by third-party inspectors. Assist project teams with QA activities for new product development and facilities.Knowledge and Skills:
In-depth knowledge of QA principles within ISO and GMP environments. Strong understanding of GMP and ISO requirements. Effective communication skills across all organizational levels. Proficiency with relevant computer software. Excellent time management and planning skills.Qualifications and Experience:
B.Pharm degree (NQF 8) or equivalent. Registration as a practicing pharmacist with the SAPC. GMP training certif
12 Apr 2025;
from:
gumtree.co.za