Qa Compliance Pharmacist

Findojobs South Africa; Oos-Kaap; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading compliance and quality assurance company in South Africa seeks a Quality Assurance Officer to monitor GMP adherence, manage product releases, and coordinate quality activities for new product launches. The ideal candidate will possess a relevant degree and have experience in quality assurance, with strong analytical skills for auditing and documentation. This role offers an opportunity to contribute to continuous improvement initiatives.

Qualifications

• Experience with GMP and compliance regulations.
• Proficiency in data entry and database management.
• Strong analytical skills for auditing and documenting processes.

Responsibilities

• Monitor manufacturing compliance with GMP.
• Manage product re-works and release according to SOPs.
• Coordinate QA activities for new product launches.

Skills

GMP compliance

Data analysis

Report generation

Quality assurance

Process improvement

Education

Relevant degree in Life Sciences or Quality Assurance

Tools

SOP documentation

Job description

Overview

• Monitor manufacturing compliance with GMP and statutory requirements.
• Ensure adherence to guidelines, procedures, and document controls.
• Achieve expected value stream targets as per business requirements.
• Maintain facility GMP compliance.
• Participate in team and process development.

Responsibilities

General Operating Activities

• Execute daily tasks and work instructions according to SOPs.
• Operate computer systems for data entry, report printing, etc.
• Perform data reconciliations and update databases.
• Edit and format SOPs as required.
• Generate reports as instructed.
• Verify data accuracy and audit documentation.
• Ensure documentation signatures are obtained and maintain proper filing.
• Perform additional work-related tasks as required.

Final Release of External Supply Products

• Review batch documentation for GMP compliance.
• Review product samples and artwork for SA Markets.
• Manage Post-Importation Testing (PIT) processes.
• Monitor blocked stock in warehouses.
• Conduct product release according to SOPs for SA and international markets.
• Manage product re-works per SOP and cGMP.
• Review data logger downloads for received products.

Investigating and Resolving QA Queries

• Coordinate feedback and reports from manufacturers and QA teams.
• Follow up on outstanding documentation and deviations.
• Approve and log deviations in consultation with QA management.
• Manage laboratory Out of Specifications (OOS) issues.
• Handle Suspect Stock Notifications and temperature excursions.
• Review raw material status and expiry data with CM.

Control of Highly Scheduled Substances

• Complete S6 requisitions and log samples.
• Maintain S6 register per MCC requirements.
• Apply for import permits for Schedule 5 and 6 medicines.
• Coordinate product launches requiring permits with MCC.
• Ensure permits are cleared and reconciled in time.

Management of QA Activities for New Product Launches and Re-alignments

• Request and review testing documents from Regulatory Authority.
• Coordinate Analytical Method Transfer (AMT) with PIT labs.
• Ensure timely ordering of reference standards and materials.
• Review batch documentation for new products or re-alignments.

QMS Metrics – SOPs, Deviations & Change Controls

• Initiate and review SOPs relevant to the role.
• Log and manage deviations and change controls.
• Conduct internal audits and compile reports.

Continuous Improvement Initiatives

• Identify process gaps and propose improvements.
• Manage assigned projects and provide progress feedback.

Human Resources and Compliance

• Adhere to company policies and labor legislation.

GMP Compliance

• Complete records and reports accurately and on time.
• Follow GMP/GLP requirements in all activities.

Health, Safety, and Environmental Standards

• Comply with OHS Act requirements and report unsafe conditions.
• Report incidents affecting health or safety.