القائمة الرئيسية

الصفحات

Compliance QA Systems Specialist at Sanofi

 Compliance QA Systems Specialist at Sanofi

Compliance QA Systems Specialist at Sanofi




JOB PURPOSE: 


Quality risk Management

Self-inspections participation

Quality shop-floor activities in Utilities (HVAC and Water stations).

Annual utilities review.

CAPA system management

Change control system management

KEY RESPONSIBILITIES AND DUTIES:


Quality Risk Management

participate in creation & Maintenance of a system capable to consistently identify, analyze, evaluate, control, communicate and review of potential or identified risks related to quality and GxP compliance in alignment with global quality documents

Creation and periodic update of site quality risk profile.

Creation and follow up implementation oof quality risk assessments master plan.


Non-Production areas shop floor activities.

To follow GMP compliance for activities done in Utilities (HVAC & Water stations) by conducting periodic tours in these areas.

Annual Utilities Review:

Prepare AUR plan and follow up the plan implementation.         

Collecting data from various departments concerned with AUR.

Reviewing & checking the collected data.

Follow up all possible corrections if any with concerned responsible person.  


Participate in Site Self inspection for GMP related areas among all industrial affairs departments

Preparation of an annual plan for internal audit for different departments on yearly basis.

Participate in Execution of the plan through conducting self-inspection in different departments.

Creation of self-inspection report within the specified timelines.

Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.

Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.

Quality maturity index tool follow up

Follow up of the quality maturity index tool periodic assessment with the concerned departments on quarter basis.

GRIC, SQRs and audits CAPAs follow up.

Co-ordinate the creation of satisfactory action plan for the communicated GRIC memos, SQR reports, and received audits or inspections by the concerned area responsible.

Responsible for CAPAs follow up :

To follow up the CAPAs implementation on monthly basis.

Follow up performance of CAPA efficiency on monthly basis.

Respect of company values, code of ethics & social charter.

Perform other duties as assigned.

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.

HSE Responsibilities in case joining HSE Excellence team:

Facilitate and guide the employees to implement the HSE&En. Policies.

Implement all applicable standards and guides of Sanofi-Aventis in his/her area.

Ensure from from complying with all legal and Sanofi-Aventis requirements.

Lead his/her team to implement the HSE & EnMS PASS.

Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.

Report any accidents/incidents in his/her area to the HSE department.

Lead his/her team for investigate accidents/incidents to define the root cause.

Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.

Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.

Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.

Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.

Define and control the required PPE’s for his/her area.

Define the list of CMR and its operational control for Quality labs and production areas.

Control the first aid kits in his/her area.

Leading his/her team for control the significant hazards /aspects and Energy use.

REQUIREMENTS:


Education:


Bachelor of Pharmaceutical Sciences.

Related Experience:


3-5 Years in related GxP area.




Apply Here

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