Website Asset Recruitment
Asset Recruitment
ref. 01142
QA Technician – Batch Documentation
Role
As a QA Technician you will be involved in ensuring the timely and efficient flow of batch documentation including tracking of paperwork through the process from manufacturing and QA, you will also manage the transfer of documentation between sites in accordance with the applicable Quality Agreement.
Duties and Responsibilities
• Support QA Specialist compiling final disposition packs.
• Maintenance and management of client review status tracker, providing Client status updates to the QA release Group Lead.
• Scanning and uploading of batch documentation and any additional documentation to the review site ensuring all documentation uploaded is in chronological order and in the correct status.
• Scanning and upload of updated batch documentation following confirmation and resolution of Client comments by the QA Release Group Lead.
• Preparation of batch disposition packs for archival and movement of batch disposition packs to the archive room.
• Movement of batch disposition packs to the archive room.
• Scanning of final batch packs and critical batch records to long term document repository (ECM).
• Perform all duties in accordance with cGMP requirements, SOPs, and controlled documents.
• Flexibility to take on additional tasks and responsibilities at the discretion of the QA DS Operations Lead.
Experience
• Experience in a GMP environment would be an advantage.
• Experience working as part of a cross departmental team.
• Experience handling batch and filing documentation .would be an advantage.
Qualifications
• A Bachelor’s degree in a Science discipline would be advantageous.
• Minimum requirement leaving certificate.
Skills
• Knowledge of cGxP requirements and regulations.
• Knowledge of trouble shooting and problem-solving skills and implementation of continuous process improvement tools.
• Demonstrated collaboration with a teamwork mindset.
• Excellent communication skills (written and oral).
• Strong attention to detail, adaptable able to multi-task