Quality Assurance Vacancy At Sanofi Egypt
Job title: Quality Manager - External Manufacturing AMET
Location: Cairo, Egypt
At Opella Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.
About the job
Manage third party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMP activities.
Serve as functional quality representative of external manufacturing AMET for CMOs in work scope.
Ensure that the transfer of a manufacturing process and analytical methods throughout product development and lifecycle, from a Sending Unit (SU) to a Receiving Unit (RU), is conducted in a planned, controlled, organised, efficient, and well documented manner with well-defined success criteria for all transfer phases.
Ensure that manufacturing operations are performed, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.
Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities.
Any ad hoc tasks assigned by the reporting Manager.
Candidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have effective communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.
Major Duties & Responsibilities
1- Quality Management of third-party manufacturers
Perform GMP audits of third-party manufacturers and CAPA (Corrective action and preventive action) follow-up.
Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
Management and support product recall and return.
Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
Participate in the evaluation, selection, and approval of third-party manufacturers.
Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
Review of technical reports e.g., stability reports, process /analytical validation reports etc.
Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.
Perform risk ranking of third-party manufacturers.
Manage termination of activity with third party manufacturers.
2- Quality Operations of EM CHC AMET Entity
Support Technology Transfer to ensure adequate process, testing, and product knowledge transfer from SU that possesses the knowledge, history, and operational experience to RU that needs to acquire the knowledge and leverage available experience to establish and sustain the transferred process and technology.
Transfers of end-to-end manufacturing processes along with their supporting analytical methods, from starting materials preparation, seed and cell bank preparation, active pharmaceutical ingredient (API) manufacturing, and formulated drug substance manufacturing to finished product (FP) manufacturing.
Support/perform management and continuous improvement of Quality Management System (QMS).
Support/perform implementation of global quality standards and procedures.
Support Quality Documentation System management, documentation Retention, Archival and Destruction.
Support/perform Qualifications and Training of Quality/Regulatory personnel.
Support/perform Self Inspection.
Prepare and participate in EM CHC AMET Quality Review.
Support/prepare Monthly Quality Reports for reporting to Global Quality.
Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers for reporting to Global Quality.
3- Quality Support for Transversal Projects
Provide Quality support for transversal project e.g., new product launch, site transfer or repatriation.
About you
Experience: 8 years working experience in quality or manufacturing in pharmaceutical industry.
Soft and technical skills:
Ability to work in a matrix organization.
Good team spirit and familiar with project development through cross-functional activities.
Strong organizational and negotiation skills.
Knowledge and understanding of Quality Control Analytical methods.
Knowledge and understanding of Installation Qualification, Operational Qualification and Process Qualification processes and techniques.
Pro-active with good sense of responsibility.
Balanced Judgment / Risk based approach.
Analytical thinking, hands-on troubleshooting style.
Able to work independently and write technical reports.
In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations).
Computer skills: Word, Excel, Phenix / CONNECT (Quality tool and GMP Documentation system).
Languages: Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
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Location: Cairo Site
Job title: Change Control Process Owner
Location: Cairo Site
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Job Purpose:
The purpose of this position is to manage and oversee the Change Control System within the organization. This role involves receiving and evaluating change control requests, coordinating with various departments to implement pre-action plans, and ensuring compliance with global regulatory requirements. The position aims to facilitate effective communication and follow-up on action plans, ultimately ensuring the successful implementation and closure of change controls. This role is essential for maintaining the integrity and quality of operations through systematic change management
Handling of Change control system
Receive a change control request form any department
Follow up of evaluation of change control request.
Communicate with the experts in concerned departments to perform the impact assessment for their area.
Follow up the implementation of the action plan with concerned departments
Evaluation of final report concerning the actions of the change.
Closing the change control
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 PQR preparation for change control chapter
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 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.
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.
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