Quality Operations
AstraZeneca and Pfizer
مجموع سنوات الخبرة :24 years, 7 أشهر
AstraZeneca USA 2014 to date
Quality Operations
Responsible for Quality oversight of manufacturing operations and execution and completion of the following: On the Floor reviews of SPR/MPRs, autoclave cycles, alarms, logbooks and temperature charts. MPR/SPR/logbook page issuance. assist in product changeover and placing equipment on QA hold.
Ensures that root cause investigations are performed, recommends and/or supports implementation of corrective actions to prevent recurrence.
Approves non-conformance in compliance with SOP and regulatory requirements per the requirements of the self-inspection program.
Manage internal tracking database (SAP, lot status, observation logs) and create monthly metrics.
Responsible for assuring the quality of products manufactured at the facility.
Coordinate with cross-functional teams in Manufacturing to define and resolve product quality problems
Perform PQA (primary quality assessments) and FQA (Final Quality Assessment) of investigations.
Ensure that corrective and preventive actions (CAPAs) are established and implemented as committed and ensure timely remediation of any issues related to CAPAs.
Pfizer Canada 2008 to 2014
Quality Assurance
Develop, and maintain product/raw materials/packaging materials specifications as per current regulations, manufacturer specifications and Pharmaceutical compendium
Assist in investigation of non-conformance, follow-up, ensuring timely review and disposition of stability results.
Draft, execute, and train QA, Production, and QC on Stability Protocols.
Work with Technical Services to define validation requirements for new processes.
Trained in using Quality Risk Management base techniques to foster the strategic business decisions
Supports Stability Program - Drafting Stability Protocols and Reports in accordance with ICH Q1, Q7 Stability guidelines and applicable standards.
Ensure the timely and accurate reporting, correction and investigation of Non-conformance associated with production activities.
Responsible to ensure production schedule and agreed upon goals and objectives are met.
Experience working in a fast paced environment.
Record keeping of all production documents according to GMP standards.
Perform start up and periodic checks to ensure that product met the specifications.
Developing strategic objectives and work with team to maximize plant utilization and efficiency
Develop IDP (Individual Development Plans) and Goals for Cross functional heads to ensure Organizational Objectives are achieved.
Facilitate Economical budget settings for all the departments and monitor the performance on a monthly basis.
Resolve issues in timely fashion, as needed
Ensure there are appropriate mechanisms and organizational structures to deal with routine operations, problem solving and troubleshooting.
Work with sales and marketing team to develop annual/quarterly production schedules and raw materials assessments.
Prepare and present technical reports for the Management Committee.
Design future plans and report on all technical investment projects.
Manage the production related tasks as required during the Bulk Manufacturing building renovation project including reviewing related specifications and documents.
Manage production staff and the continuity plan as identified, modifying as needed to ensure Manufacturing needs.
Manage production scheduling within the department, creating schedules when required for validation activities and for the shut-down and start-up activities specific to the area or platform.
Act as the point of contact for production related issues.
Participate in special projects as required, testing and validation exercises and/or troubleshooting for facilities or engineering related issues.
Lead or participate in non-conformance investigations, associated CAPAs and SOPs/SWIs as well as Change Controls (project or non-project related)
Designed the new plant, erection / construction of plant.
Registration of products, regulatory audits, and other regulatory related activities.
Validation studies including IQ, OQ, PQ, drafted protocols, executed the studies
Drafted procedures for operations, security matters, and personnel entry procedures.
Co-ordinates with contractors to bring the company in production as per plan.
Trained the directors, personnel and brought the company in production.
Ensure successful and timely resolution of audit actions.
Coordinate with Quality group in discrepancy resolution
Manage the manufacturing, filling, sterilization and packaging of products
Plan, Hire, train, develop and maintain skilled staff.
Review of Environmental Monitoring data and implementation of corrective actions, if needed.
Maintain Master Batch Records as per current guidelines.
Coordinate for timely issuance manufacturing and packaging orders.
Prepare annual and five years forecasting/budget
Coordinate with technical services for implementing validation activities
Ensure compliance to site procedures, GMP and regulatory guidelines.
Schedule manufacturing and packaging plans as per market needs.
Ensure timely initiation and implementation of change controls
Ensure equipment, clean areas and building is properly maintained
Pharmaceutical Regulatory Affairs, Product Formulation, Quality Assurance, Biotechnology, Technical Writing and Communication.
Major Courses; Total Quality Management, Human Resource Management, Business Law, Business Math and stat., Business Communication, Economic Analysis, Management Information System, etc
Major Courses: Industrial Pharmacy, Pharmacology, Pharmaceutics, Physiology, Applied Math and Statistics, Pharmaceutical Biochemistry, etc.