Quality Pharmacist - #305626

Aspen Pharma Group


Date: 2 weeks ago
City: Port Elizabeth, Eastern Cape
Contract type: Full time

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.

Planning and Process

  • 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 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.

Process Compliance

  • Identify systematic technical and process issues by reviewing CAPA requests and trends.
  • Systematic investigation of the root causes 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 analyzed 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 analyze 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 if 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 standardized reports and consolidate standardized documents.


Skills Required

  • 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

  • Demonstrate initiative and apply advanced concepts.
  • Exercise interpersonal, communication, training, and problem-solving skills to optimize team performance.
  • Escalate highly complex problems or out-of-policy issues.
  • Work on assignments of moderate size, scope, diversity and/ or complexity
  • Stay up to date on developments, trends, legislation and industry regulations in pharmaceutical industry.

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