QUALITY ASSURANCE SPECIALIST
Abbott Laboratories
Total des années d'expérience :11 years, 7 Mois
Quality compliance Support for below activities during Product
development, technology transfer including;
• Technology Transfer plan/ Test Method Transfer/Analytical
Method Validation/Verification/Stability program and shelf-Life of
the product.
• Provide contributions for the Product technical knowledge during
and after technology transfer and ensure the product meeting the
Quality Standards.
• Product robustness from sending unit and complete the package
during technology transfer.
QA Technical Support activities;
• QA representative in the New Product Introduction process.
• Involve in support the quality aspects of the Product Portfolio
Expansion Initiatives and Geographic Expansion initiatives and other
Non-Centrally Supported Products.
• Quality and compliance of the product and process during
identification of the commercial manufacturing site and all the
technology and/or analytical method transfers and improvements
• Supporting in product and process quality and compliance
throughout the maturity stage of the life cycle of commercialized
products.
• Coordinate Stability Risk Assessment activities for assigned projects.
• Serve as quality
Pharmaceutical UAE.
• On Job Training (OJT) Coordinator at Julphar Training Center (JTC)
• (OJT may be one of the most effective forms of training, usually
performed by a qualified subject matter expert or 'SME' or
qualified
• Supervision. Caution should be taken that product is not
manufactured or tested by an unskilled individual who is
Dispensing prescription medicines.
• Ensuring that different treatments are compatible.
• Checking dosage and ensuring that medicines are correctly and
safely supplied and labelled
• Supervising the preparation of any medicines (not all are supplied
ready made-up by the manufacturer).
• keeping a register of controlled drugs for legal and stock control
purposes.
• liaising with doctors about prescriptions.
• selling over-the-counter medicines.
• offering a diabetes screening service.
• arranging the delivery of prescription medicines to patients.
• budgeting and financial management.
• keeping up to date with current pharmacy practice, new drugs and
their uses.
Sampling and testing of raw materials, intermediates and finished
products using current pharmacopoeias, any associated ‘wet’
chemistry and instrumental techniques (HPLC, IR, UV), as
appropriate.
• Preparing Quality reports, including analytical reports (for raw
materials and finished products), Certificates of Analysis (CoA) (for
finished products) and stability reports.
• Creating and executing method development and method
validation test protocols for finished products and generating the
appropriate analytical methods. ·
• Stability testing of products for new formulations and ongoing
stability trials, using physical (pH, viscosity) and instrumental
(HPLC, UV) techniques, as appropriate.
• Writing analytical specifications using current pharmacopoeias and
reviewing existing analytical specifications.
• Writing/reviewing Standard Operating Procedures (SOPs).
• Calibrating analytical equipment, as and when required. ·
• Supporting all QC activities.
Pharmaceutical Science