QS Compliance Pharmacist Assistant

Aspen Pharma Group; Gqeberha; On-site; ZAR 250,000 - 350,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Compliance Assistant in Port Elizabeth. The role focuses on ensuring adherence to GMP standards, managing inspections, and training personnel. Ideal candidates will have a keen eye for detail and expertise in compliance practices.

Qualifications

• Strong understanding of GMP and statutory compliance.
• Experience with inspections and document controls.
• Ability to perform and verify calculations in BMR.

Responsibilities

• Monitor compliance to GMP and handle inspections.
• Conduct environmental checks and training for PMAs.
• Manage change control programs and customer complaints.

Skills

Attention to detail

Problem-solving

GMP compliance knowledge

Training

Job description

Monitor manufacturing compliance to GMP and statutory requirements

Monitor adherence to guidelines, procedures, and document controls

Related support and administrative tasks

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

Complete batch records and labels

Query documents and sign off declarations

Perform and verify calculations in BMR

Maintain and update records and systems as required

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Compliance Assistant • Port Elizabeth, ZA