Quality Pharmacist (Port Elizabeth) at Aspen Pharma Group

Overview

•  Conduct in-process compliance to quality procedures, standards and specifications for value stream operations 
•  Review and approve Annual Performance Quality Review (APQR) and quality related activities
•  Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs
•  Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines
•  Control of documentation in compliance with regulation and company policies and procedures
•  Ensure all relevant GMP and GDP processes are described in the current SOPs and re-adhered to correctly 
•  Perform quality risk assessments, establish risk controls and review risks to assist with the quality risk management process

Responsibilities

Planning & Processes 

•  Provide technical and operational input during drafting of plans and procedures specific to unit 
•  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 and risk associated with planned changes / deviations 
•  Ensure production and QC documentation are completed an 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

Process Compliance

•  Identify systematic technical and process issues by reviewing CAPA requests and trends
•  Systematic investigation of the root cause of identified problems and risks for corrective action or prevention 
•  Develop CAPA plans and change incidents to address process compliance
•  Implement operational changes to SOPs and processes, in compliance with control processes
•  Ensure deviations (planned / unplanned) are documented, reviewed, and analysed and recommend validation activities to be performed 
•  Execute change control process by ensuring changes are documented, reviewed and approved

Annual Performance Quality Review

•  Review APQRs to assess production risks and quality of in-process control programs
•  Review and analyse CAPA plans to assess impact on quality procedures and standards

Retention Sample Management

•  Store and manage retention samples as per guidelines

In Process Quality Management 

•  Review and approve outcome of in-process internal inspections

Reporting 

•  Ensure the filing, retrieving and archiving of documents on the soft and hard copy filing systems 
•  Maintain and update records and systems as required
•  Provide information for reports on weekly / monthly basis, as required by superiors
•  Compile and complete standardised reports and consolidate standardised documents 

Requirements
Skills required

Background/experience

•  BPharm Degree with 2 years’ pharmaceutical manufacturing experience
•  South African Pharmacy Council registration 
•  1-year related work experience 

Specific job skills

•  Advanced understanding of the 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
•  Finalising Outputs
•  Offering Insights
•  Meets Deadlines 
•  Taking Action