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
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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