Description
Overview

Monitor and report on manufacturing compliance to GMP and statutory requirements
Ensure adherence to guidelines, procedures, document controls and support with related administrative task

Requirements
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

Skills Required
Background/experience

Post Basic Registration with the Pharmacy Council
1-3 years’ related experience in manufacturing
Pharmaceutical manufacturing and/ or Pharmacist Assistant experience

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

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