Quality Assurance Supervisor
Advanced Medical Industries
Total years of experience :17 years, 6 Months
Supervise, develop, manage and train the personnel in quality assurance.
Development and maintenance of the quality management system within AMI, including elaboration of QA procedures, and ensuring that applicable GMP compliance is integrated in the system and documents.
Follow developments within technical/scientific areas of interest, including regulatory requirements, guidelines, and GMP trends.
Reviewing documents provided by other team members to assure compliance with the regulations and batch record release.
Oversight for calibration and maintenance system being in place.
Authorization of SOPs and qualification documents. Authorization includes a review of the content for applicability in connection with customer audits/inspections as well as GMP compliance.
Participation in Change Control Committee, evaluation and authorization of production trials/change controls and final authorization of changes.
Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and environmental monitoring.
Audits.
Host and follow up on inspections by regulatory agencies.
Consultancy in connection with quality issues.
Collecting data for the Quality Monthly Report.
Full oversee the production of blood lines tubing system line by standard methods of work and ensure product quality according to international standards ISO 9001.
Follow-up of all the company's transactions with the Food and Drug Administration JFDA.
Supporting manufacturing and other operation in the maintenance of cGMP.
Reviewing and approving batch manufacturing documentation for timely release.
Monitoring quality in the production environment and Documenting results.
Recommending new procedures and work instructions.
Performing internal inspections and audits and continuing staff training regarding various procedures and concepts.
Releasing bulk and finished goods as well as packaging materials.
Writing QA procedures and assisting all other departments in regards to procedures and all other quality matters.
Participating in the evaluation of quality events, incidents and possible complaints and the follow-up activities.
Occupational Safety & Health supervisor: 21Jun. /2009 - 23Aug. /2015
Maintaining a safe and hygienic environment in the factory.
Assisting with local Health and Safety management, covering all staff, equipment and other related items.
Writing safety procedures and assisting all other departments in regards to procedures and all other safety matters.
Taste test of finished products and in-line monitoring of products.
Checking products and make sure that they are free from defects and adhere to quality standards.
Constant oversight in the factory with daily reports on quality and production status.
Inspection of machinery and materials to be used for order prior to production.
Guarantee the finished and packed goods meet specifications (product type and quantity) and are securely loaded for shipment.
Performing Laboratory Testing (flavours, gas contain and sugar percentage).
Applied Chemistry
Scientific