Quality Assurance Manager
Plastimed
Total years of experience :7 years, 9 Months
Create the whole Quality Management System for PLASTIMED company
•Maintain and improve company documentation system as per ISO9001:20015 requirements
•Maintain and improve all aspects of PLASTIMED pharmaceutical quality system as per international norms and standards such as: ISO 9001:2015, European GMP Eudralex, WHO GMP
•Control and distribute quality assurance tasks to QA inspectors and officers which covers quality inspections for Manufacturing, Quality control laboratories, storage warehouses and water treatment system
•Ensure internal/external audits and management review are being conducted as per schedule
•Ensure that process deviations, customer complaints, returned product and non-conforming products are being handled properly by the quality team
•Ensure all CAPAs are effective and handled properly within the deadline
•Ensure that all validation and qualification activities are being performed properly according to approved references and properly documented
•Ensure that all warehouse activities are being implemented according to GSDP guidance
Conduct regular quality assurance inspections on site to closely monitor the overall manufacturing operations and to ensure that the established company quality assurance system is well implemented.
Assist Technical Development officer to track and update Validation Program: DQ, OQ, IQ and PQ
Ensure USP, GMP and GSDP standers are will respected.
Assist the Quality Assurance Officer in handling all quality assurance activities as per policies and procedures.
Conduct quality inspections and internal quality audits to make sure the company’s quality assurance system is well implemented according to ISO 9001:2015 and Good Manufacturing Practices requirements (EU).
Assist in writing and editing quality assurance documents.
Participate in deviations, CAPA, out of specifications, improvement action forms, non-conforming products, customer complaints and product recalls, investigations and management.
Conduct line clearance and quality inspections on time.
Conduct quality inspections to ensure that personnel hygiene and gowning standards are followed by all employees.
Follow and apply the company’s quality system based on Good Manufacturing Practices and ISO 9001:2015 requirements.
Accept and work any task related to QA activity.
Perform internal laboratory tests (physico-chemical and microbiology)
Control and improve company documentation system as per ISO9001-2015 requirements
Ensure that food safety hazards are identified, evaluated and controlled in such a manner that the products of the organization do not, directly or indirectly, harm the consumer.
Communicates information concerning development, implementation and updating of the food safety management system throughout the organization, to the extent necessary to ensure the food safety required by ISO22000.
Assist in evaluating periodically, through internal/external audits
GMP checklist
Employees Health and Hygiene Checklist
Chiller/Freezer temperature monitoring sheet
Check up on cleaning procedure
Products recall
Traceability, Chlorine level in water, Pest activity sighting
courses: 2011 Zahia Salman Secondary Official School