QS Compliance Pharmacist Assistant at Aspen Pharma Group

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/experiencePost 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