QA External Manufacturing Professional At Sanofi
QA Specialist - External Manufacturing
JOB PURPOSE:
Participate in management of external manufacturing activities, auditing, Product Technical Complaints
KEY RESPONSIBILITIES AND DUTIES:
Participate in external manufacturing activities:
Preparation of Quality agreements with manufacturing subcontractors performing activities on behalf of SANOFI and follow up of its approval.
Following up CAPA implementation of external audits.
Frequent visits to subcontractors to follow up the process and to ensure the compliance to cGMP, SANOFI requirements when applicable and with local regulations.
Participate in externalization projects to CMOs regarding quality activities.
Review of CMOs quality documents including validation documents, deviation reports, change control requests, APRs, products QSMPs within specified timelines.
Conduct gap analysis for CMOs management global guidelines.
Keep QTP module updated with CMOs related information.
Perform final release of toll out products within the specified timelines.
Preparation of external manufacturing quality Monthly report.
Conduct annual quality review for the CMOs.
Participate in suppliers & subcontractors audits:
Preparation of annual plan for subcontractors’ audits on yearly basis.
Participate in external audits for suppliers & subcontractors.
Participate of Product Technical Complaints Handling:
Participate in investigating, root cause identification and action plan follow up for all Sanofi Customer Complaints.
Communication and follow up customer complaint investigation related for toll out products at COMs level.
Participate in Quality Risk Management:
Participate in identifying, analyzing, evaluating, controlling, communicating, and reviewing potential or identified risks related to quality and GxP compliance in alignment with global quality documents.
Work as risk assessments facilitator for the assigned risks.
SAP Activities:
Participate in Approval of finished/ semi-finished product recipes on SAP Athena.
Participate in Creation/update of Quality Info Records for materials on SAP Athena.
Participate in Creation of Inspection Plan for materials on SAP Athena.
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 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.
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Education:
Bachelor of Pharmaceutical Sciences.
Related Experience:
3 - 5 years in related GxP area
Experience in QA and Validation is a must
Special Knowledge/Skills:
Good communication & Presentation skills.
Planning & organizing skills
Problem solving skills.
Report writing skills.
Ability to co-ordinate several inter-departmental activities.
Good command of MS Word, Excel & Power Point.
Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
Validation theories, methodologies.