QA Compliance Pharmacist

Aspen Pharma Group; Gqeberha; On-site; ZAR 300,000 - 450,000; Full time

Job summary

A leading pharmaceutical company in Gqeberha is seeking a Quality Assurance professional to ensure compliance with GMP standards. You will monitor manufacturing processes, review batch documentation, and manage QA queries. The role requires strong attention to detail and experience in quality assurance practices in the pharmaceutical industry.

Qualifications

• Experience with manufacturing compliance and quality assurance processes.
• Ability to manage documentation effectively.
• Strong understanding of regulatory requirements pertaining to pharmaceuticals.

Responsibilities

• Monitor manufacturing compliance with GMP and statutory requirements.
• Review batch documentation for GMP compliance.
• Manage QA queries and product releases.

Skills

GMP Compliance

Data analysis

Documentation management

Problem-solving

Communication skills

Education

Relevant degree in Life Sciences or Quality Assurance

Tools

Baan system

Job description

Overview

• Monitor manufacturing compliance with GMP and statutory requirements.
• Ensure adherence to guidelines, procedures, and document controls.
• Deliver value stream targets as per business needs.
• Maintain facility GMP compliance.
• Develop team and processes.

Responsibilities

General Operating Activities

• Execute daily tasks and work instructions according to SOPs.
• Operate computer systems, capture data, and print reports.
• Perform data reconciliations.
• Update and maintain databases.
• Edit and format SOPs as needed.
• Generate reports as instructed.
• Verify data accuracy and audit documentation.
• Obtain necessary signatures for documentation completion.
• Maintain proper filing and retrieval of documents.
• Perform other 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.
• Ensure product release follows SOP 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

• Follow up on QA queries with manufacturers and QA management.
• Track outstanding reports and deviations.
• Approve and log deviations in consultation with QA.
• Manage laboratory Out of Specifications (OOS) issues.
• Handle Suspect Stock Notifications and temperature excursions.
• Review raw material status and expiry dates.
• Update the Baan system accordingly.

Control of Highly Scheduled Substances

• Complete S6 requisitions and log samples.
• Maintain S6 register as per MCC requirements.
• Apply for import permits for Schedule 5 and 6 medicines.
• Coordinate with logistics to ensure permits are obtained and cleared.

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

• Request and review testing documents from regulatory authorities.
• Coordinate analytical method transfer and oversee documentation.
• Ensure timely ordering of reference standards and materials.
• Review batch documentation for initial batches of new launches.

QMS Metrics – SOPs, Deviations & Change Controls

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

Continuous Improvement Initiatives

• Identify process gaps and propose improvements.
• Streamline processes for quicker QA activities.
• Manage assigned projects and report progress.

Human Resources & Compliance

• Follow company policies and procedures.

GMP Compliance

• Complete records and reports accurately and timely.
• Adhere to GMP/GLP requirements.
• Handle products as per SOPs and documentation.

Health, Safety, and Environmental Standards

• Follow OHS Act requirements and SHE procedures.
• Report unsafe situations and incidents.