Computerized Systems Compliance Specialist

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.

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

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