Pharma Affairs Budget Associate : Aspen Holdings Aspen Holdings



Job Summary


Monitor and report on manufacturing compliance to GMP and statutory requirements, adherence to guidelines, procedures and document controls.

Duties and Responsibilities


 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

Qualifications and Experience


Background/experience
•Post Basic Certicate/ Higher Cerificate in Pharmacist Assistant
Pharmaceutical manufacturing 1 - 3 years
•Registered Pharmacist Assistant with the Pharmacy Council

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

How to Apply


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