QS Compliance Pharmacist Assistant

Aspen Pharma Group; Gqeberha; On-site; ZAR 50,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Gqeberha is seeking a compliance officer to monitor manufacturing processes, ensure adherence to GMP standards, and conduct training for new staff. The role involves regular inspections, auditing compliance, and optimizing processes. Ideal candidates should have experience in manufacturing compliance and quality control processes, along with strong organizational skills.

Qualifications

• Experience in manufacturing compliance and GMP.
• Familiarity with inspections and quality control processes.
• Ability to train new personnel on SOPs.

Responsibilities

• Monitor manufacturing compliance to GMP and statutory requirements.
• Perform visual inspections of rooms, machine parts, and equipment.
• Conduct shift GMP checks and ensure continued compliance.

Job description

Overview

Monitor manufacturing compliance to GMP and statutory requirements

Monitor adherence to guidelines, procedures, and document controls

Related support and administrative tasks

Responsibilities

Inspections and Verifications

• Perform visual inspections of rooms, machine parts and equipment
• Verify that rooms and equipment are certified clean as per SOP
• Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
• Verify daily sampling, dispensing of materials and its mass / volume
• Perform housekeeping of rooms and equipment

Line & Production processing

• Perform line sign-on and closure
• Check and authorise packaging line clearance
• Order and maintain substance materials
• Perform batch reconciliations to product specifications and quality
• Monitor production process in line with standards and specifications

Process and system improvements

• Manage change control programs and deviations / concessions in line with SOPs, standards and product quality and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies / procedures

Compliance & Auditing

• Conduct shift GMP checks and ensure continued compliance
• Conduct environmental checks and check expiry dates of agents
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Check preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new PMAs on SOPs
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required