QA Specialist

Position Summary

The QA Specialist provides Quality Assurance support for Investigational Medicinal Product (IMP) manufacturing and associated Quality Management Systems at Med Pharm.

The role is responsible for supporting compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), applicable regulatory requirements and internal quality procedures through the review of quality documentation, management of quality systems and QA oversight of manufacturing and laboratory activities.

The QA Specialist works closely with Production, Quality Control, Pharmaceutical Development and other departments to ensure quality systems remain effective, regulatory expectations are met, and products are manufactured and released in compliance with applicable legislation and client requirements.

• Quality Management System
  • Raise, review and manage Quality Management System (QMS) records including deviations, change controls, CAPAs, investigations, complaints and quality risk assessments.
  • Support timely progression and closure of quality records in accordance with internal procedures.
  • Ensure quality records are complete, scientifically justified and compliant with regulatory expectations.
  • Support continuous improvement of Quality Management System processes.
• Documentation Control
  • Review and approve controlled documents including SOPs, forms, protocols, reports, specifications and quality records within the electronic Quality Management System (eQMS).
  • Ensure documentation complies with Good Documentation Practice (GDP) and ALCOA+ data integrity principles.
  • Maintain document control processes including document issuance, revision, archival and retention.
  • Support management of controlled templates and quality documentation.
• Manufacturing QA Oversight
  • Perform QA review of Batch Manufacturing Records (BMRs) before manufacture where applicable.
  • Review completed manufacturing documentation for completeness, accuracy and compliance prior to QP certification.
  • Provide QA support during manufacturing activities as required.
  • Support review of manufacturing investigations and manufacturing deviations.
  • Escalate quality concerns where product quality or patient safety may be impacted.
• Laboratory QA Support
  • Review Quality Control documentation including specifications, analytical methods, sampling instructions and protocols.
  • Support review of analytical investigations including OOS, OOT and atypical results.
  • Review laboratory documentation to ensure compliance with GMP, GLP and internal procedures.
  • Support QA oversight of reference standards, retained samples and stability documentation where applicable.
• Materials Management
  • Perform QA review and disposition of starting materials, packaging materials and finished products in accordance with approved procedures and delegated QA authority.
  • Support supplier qualification activities including supplier assessments, audits and technical agreements.
  • Support ongoing supplier performance monitoring.
• Audits and Inspections
  • Participate in internal self-inspections and supplier audits.
  • Support preparation for customer audits and regulatory inspections.
  • Assist with implementation and follow-up of audit observations and CAPAs.
  • Support inspection readiness activities across the site
• Data Integrity
  • Ensure quality documentation and electronic records comply with applicable data integrity requirements.
  • Promote Good Documentation Practice throughout the organisation.
  • Identify and elevate potential data integrity concerns.
• Training
  • Support implementation of Quality Assurance procedures across the organisation.
  • Deliver or assist with GMP and Quality training where required.
  • Support maintenance of QA training records.
• Archiving
  • Act as GLP Archivist where applicable.
  • Coordinate archiving activities in accordance with company procedures and regulatory requirements.
  • Ensure records are retained and retrieved in accordance with approved retention schedules.
• Continuous Improvement
  • Identify opportunities to improve Quality Systems and regulatory compliance.
  • Participate in quality improvement projects.
  • Support implementation of new quality processes and systems.
  • Support quality metric reporting and trend analysis.
• General
  • Build effective working relationships with internal departments, clients and external service providers.
  • Maintain current knowledge of applicable GMP, GCP, GLP and regulatory requirements.
  • Perform other duties appropriate to the position as requested by QA Management

• Heads of Departments
• Senior Management
• Production
• Pharmaceutical Development
• Quality Control
• External Contractors (including specialists)
• Vendors/Suppliers
• Qualified Persons
• Contract Laboratories

None

• Bachelor’s or Master’s degree in a scientific discipline (e.g., Pharmaceutical Sciences, Chemistry, Biology, or related field) or equivalent industry experience desirable but not essential.
• Minimum 2 years’ experience in a GMP-regulated pharmaceutical or biotechnology…