Quality Assurance Officer

6 months ago


Dubai, United Arab Emirates Cellsave Arabia Full time

The staff will file QMS documentation and norms(applicable; expired; withdrawn versions)
- The staff will maintain the list of QMS documentation and norms to update and make sure QMS is reviewed and approved.
- The staff will distribute and eliminate copies of QMS documentation in a controlled way and organize controlled, obsolete and archived records.
- The staff will register DCPR deviation reports, register in excel and database, assign a DCPR number, review the deviations, and perform follow up with corrective actions. Ensure timely closure and documentation of DCPR.
- The staff will assign a change request number and make changes to documents, and is responsible of registering, processing, updating, releasing and closing the documents.
- The staff will send a report of the client documentation summary on a monthly basis.
- The staff will initiate a monthly management review checklist and complete the tasks required as per checklist
- The staff will send daily QA end of the day reports to the lab Director
- The staff will check the tasks in the quality calendar and assign tasks to the responsible department.
- The staff shall design a design goal, design requirement and the design output.
- The staff is responsible for quality check of the database, review the contents of the checklist and ensure all documents (notifications, DCPR,etc.) have been filled accordingly.
- The staff will develop and effectively implement quality and operational policies, processes, and procedures to ensure the requirements of the AABB standards are met as per the company objective.
- The staff will ensure all policies, processes and procedures are in writing or captured electronically and shall be followed.
- The staff will review and sign the client certificate before final dispatch.
- The staff will verify the storage agreement and assure that it has been completed and signed on the timely manner
- The staff is responsible of ensuring the proficiency testing has been received and monitor the due date and make sure the results are entered on a timely manner.
- The staff will conduct a quality check on the kit content before distribution.
- The staff is responsible for maintaining the equipment files.
- The staff will review and sign the CBU and CTU worksheet and checks the database.
- The staff shall implement the systems in place as per the quality manual designed by the company.
- The staff will implement and maintain policies, processes, and procedures for scheduling and conducting internal assessments that shall be reviewed by personnel independent of those having direct responsibility for the activity being assessed.
- The staff will ensure that the medical director shall review and approve all medical policies, processes, and procedures.
- The staff will ensure that the laboratory director shall review and approve all technical policies, processes, and procedures.
- The staff will ensure all staff is trained on emergency operation plans (including policies, processes, and procedures) to respond to the effects of disasters and other emergencies.
- The staff will train the new staff in various policies, processes and procedures in regards to the quality system.
- The staff is responsible of reviewing the staff annual competency, staff documents, trainings and training competencies..
- The staff will look after the internal quality control requirements especially in relation to the supplier evaluations, stock verifications and approval of stock for manufacturing use.
- The staff will design and approve all the validations and necessary studies required for the same.
- The staff shall be responsible for all the document approval and tracking for all the policies, processes and procedures.
- The staff shall establish and maintain policies, processes and procedures to control, maintain and monitor critical equipment.
- The staff shall assign and maintain a unique identifier for all the records, policies, standard operating procedures, forms, annexure, files and documents.

The staff is delegated to be the back-up laboratory technician when need arises.

Application Question(s):

- Experience in quality assurance, quality control and SOP writing
- Experience in accreditations, inspections and regulations related to the field

RELEVANT SKILLS
- Trained in SOP writing, received training in Internal Audits

ANY OTHER SKILL/S
- Suitable skills applicable for the job description
- Knowledge of Computers and Statistical Programs
- Fluent in written and spoken English
- Understanding and speaking of Arabic is advantageous
- Ability to travel
- Good communication skill.
- Basic working knowledge of computers.
- Suitability for the job profile and adaptability for newer tasks.



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