Quality Assurance Administrator Reed

Our client is seeking a dedicated Quality Assurance Administrator to support the daily quality operations, ensuring compliance with internal procedures and regulatory requirements. This role is crucial for maintaining the integrity of quality systems, enabling timely product release, and fostering continuous quality improvement.

• Ensure all QA activities and documentation comply with SOPs, GMP/GDP, and regulatory guidelines (MIA/WDA).
• Maintain accurate quality records and assist with document reviews.
• Generate test request forms and coordinate sample submission to Quality Control (QC).
• Manage sample photographs and review/download data logger information.
• Review batch documents, Certificates of Analysis (COAs), stability data, and data logger results.
• Coordinate with QC, Warehouse, Finished Product sites, Logistics, and QPs to support timely batch release.
• Assist in receiving, coordinating, and responding to customer market complaints.
• Support investigations and documentation activities.
• Initiate, review, and track Change Controls, Deviations, and CAPA to ensure timely closure.
• Prepare, review, and complete Product Quality Reviews (PQRs).
• Review and update TSE/BSE declarations.
• Ensure compliance with WDA and Controlled Drug (CD) requirements.
• Support internal and external audits and prepare audit responses.
• Maintain and update Supply Chain Pedigree documentation.
• Review and approve Analytical Method Transfer protocols and reports.
• Create and update master data in Pharmanet, including materials, customers, vendors, addresses, laboratories, and manufacturing/supplier sites.
• Coordinate with subcontractors for new product launches and related QA activities.
• Identify employee training needs and support delivery of required training.

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field (or equivalent).
• Strong attention to detail and accuracy in documentation.
• Basic understanding of GMP/GDP and pharmaceutical regulatory requirements (preferred).
• Good communication and teamwork skills.
• Ability to coordinate effectively with multiple departments.