Computerized Systems Compliance Specialist

16 سبتمبر، 2022

0 3 3 دقائق

الوصف الوظيفي

JOB PURPOSE:
Assurance of the validity of various Computerized Systems to ensure their consistency & reproducibility through planning & performing all validation activities in coordination with various departments involved.
Support in Execution and Review Calibration and Qualification Activities for all critical instruments, equipment, and other supporting systems in the site.
KEY RESPONSIBILITIES AND DUTIES:

*1. Management of Computerized Systems Compliance

Reviewing of SANOFI CS guidelines to ensure internal systems compliance.

Collecting & analyzing data related to CS management from various departments.

Perform risk assessment for each CS and define its criticality.

Issuing the annual CS inventory document & CS Validation plan.

Archiving and Retention of CS compliance packages.

Follow-up & update compliance of IA CSs in various departments.

Participate in preparation of the IQ/OQ protocols of all CSs with the concerned department.

Witness and Revision of the execution of the IQ/OQ activities of all CSs and preparation of the final validation report.

Perform Gap analysis for CSs in compliance to data integrity requirements.
2. Management of Data Integrity Program

Management of Data Integrity master plan.

Management of Data Integrity program in the site.

Training of all staff members on data integrity requirements.

Lead data integrity governance team members for implementation of ALCOA+ rules in all areas.

Follow-up with data integrity governance team members the training of operators and technicians in all IA areas.
3. Equipment and Systems Qualification & Validation

Reviewing of the validation packages of new CSs before execution.

Confirm compliance of new CSs by witnessing the validation activity executed by the supplier or the ITS department and reviewing the validation packages.

Collecting data from the various departments, analyzing information provided & preparing report to include results & final conclusion of validation.

Is the validation team leader for qualification of new machines, systems or equipment.
4. HSE Responsibilities:

Ensures HSE approval on any SOP that requires certain HSE precautions.

Ensures HSE approval on any change.

Follow the laboratory safety procedures

Commitment to the appropriate PPE use.

Follow the approved HSE policy and requirements.

Following the statutory legislation concerning Health, Safety and environmental law.

Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
5. Others:

Perform other duties as assigned.

Respect of company’s values, code of ethics and social charter.

Respect of personal data protection charter.

Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS
1. Education
Bachelor of Pharmaceutical Sciences.
2. Related Experience
3 – 5 years` experience in related quality assurance function.
3. Special Knowledge/Skills

Communication, Presentation & Computer skills.

Sense of urgency & Follow up skills.

Time management – High organization & planning skills.

Good Command of English Language.

Attention to Details, Hard Worker, and Team Worker
4. Competencies

Stretch to go beyond the level we have operated at up until now

Take actions instead of waiting to be told what to do

Act in the interest of our patients and customers

Put the interests of the organization ahead of my own or those of our team

Act for Change, strive for results, Cooperate Transversally, Commit to Customer

Think Strategically, Lead Teams, Develop People, Make Decisions

Pursue progress, discover extraordinary*
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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