Release Pharmacist at Aspen Pharma Group

Overview

• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs. Determine product release for use into the marketplace. Control of documentation in compliance with regulation and company policies and procedures and perform related administrative tasks

Responsibilities

Planning and Processes

• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors
   

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
• Approve and release production batches
• Execute batch release priorities in line with OTIF and planning schedule
• Ensure release requirements are met for finished products
• Determine disposition of in-process and finished products for clinical and commercial use
• Ensure changes/ deviations in production or quality control have been approved according to QMS
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/deviations
• Ensure production and QC documentation are completed in compliance with SOPs
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
• Report observed deficiencies in process and follow up on corrective action
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production
• Provide input into GMP-related training needs
   

Reporting

• Complete and consolidate standard documents
• File, archive and retrieve documents
• Maintain and update records and systems as required
   

Requirements

Background/experience

• Bachelor’s degree with 2-4 years’ related work experience, or Post Graduate Degree/ Diploma with 1-3 years’ related work experience
• Pharmaceutical manufacturing experience
   

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives
   

Competencies

• Information Gathering
• Interrogating Information
• Meeting Deadlines
• Finalising Output
• Taking Action