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 Compliance QA Systems Specialist at Sanofi

Compliance QA Systems Specialist at Sanofi


Job Purpose:

Management of QA Systems Activities “Change Control, Complaints, CAPA, etc...”

KEY RESPONSIBILITIES AND DUTIES:

Responsible for:

Change Control Management activities:

Receive a change control request form any department by Phenix system

Follow up of evaluation of change control request risk with Quality Operations head.

Communicate with the experts in concerned departments to perform the pre-actions plan

Communicate CCC/CCP if needed for any change with global regulatory impact.

Follow up the implementation of the action plan with concerned departments by Phenix system.

Evaluation of final report concerning the actions of the change.

Change control closing.

Reporting the Change Control status on monthly basis.

Follow up the implementation of the action plan with concerned departments’ delegates in the Change Control Committee & Follow up Meetings.

Support in APR preparation for change control

Participate in Product Technical Complaints handling

Participate in investigating, root cause identification and CAPA follow-up or all customer complaints

Participate in CAPAs follow up:

To follow up the CAPAs implementation on monthly basis.

Supporting in Shopfloor activities.

Performing other QA systems activities 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 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 it’s 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.

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:

Education:

Bachelor of Pharmaceutical Sciences.
Related Experience:

3- 5 years’ experience in related positions.
Special Knowledge/Skills:

Good communication skills.
Problem solving skills.
Report writing skills.
Ability to co-ordinate several inter-departmental activities.
Good command of MS Word, Excel & Power Point.
Validation theories, methodologies.
Good Manufacturing Practices (GMP).
competencies:

Strong background for GMP in manufacturing site is a must.
Quality Assurance background in Sterile &/or Non-sterile facility is a must.
Validation & Regulatory background would be an asset.
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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