Qs Compliance Pharmacist Assistant

2 days ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**
- Monitor manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures, and document controls
- Related support and administrative tasks

**R**esponsibilities

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

**Requirements**:
**Background/experience**- Post Basic registration as Pharmacist Assistant with Pharmacy Council
- 1-3 years’ Pharmacist Assistant experience
- Pharmaceutical manufacturing experience advantageous

**Specific job skills**:

- Basic technical knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**:

- Interrogating information
- Meeting deadline
- Finalising outputs
- Maintaining accuracy

**Accountability and Decision Rights**

? Timely and accurate performance of responsibilities for a single technical area or group of closely related tasks, under supervision
? Learn and implement policies, procedures, quality and compliance standards
? Recognise and resolve basic, routine or common/ repetitive problems
? Seek assistance on complex issues and referring non-prescribed matters
? Stay up to date on legislation and industry regulations

**Decisions relating to**:
? Own work, within limited, defined parameters
? Prioritisation of basic tasks, with clear guidance

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