QS Compliance Pharmacist Assistant

QS Compliance Pharmacist Assistant
Aspen Pharma Group
2023-06-30 Port Elizabeth

Job Ref #: AMP30
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1

Applications are invited for the above indicated vacancy that exists in the Quality Systems department in Gqeberha. The successful incumbent will report to the Quality Systems Manager. All applications are to be received on or before 07 July 2023. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job Description

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


 

Job Requirements

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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