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Quality Operations Head

Synthorx

Synthorx

Operations, Quality Assurance
Cairo Governorate, Egypt
Posted on Thursday, February 8, 2024

JOB PURPOSE:

To ensure the presence of quality Systems in place in all industrial Affairs processes (Production, Quality Control, Warehouses, etc) that focus on building the quality into the product with its pre-determined specifications and compliance to GMP regulations, sanofi Global Quality Directives, standards & guidelines & national regulatory requirements.

KEY RESPONSIBILITIES AND DUTIES:

1- Release batches:

Acceptance or rejection of all materials and products responsibility is delegated to QC Manager for materials and to QA Manager for products. Final disposition decision for batches with major deviations or OOS.

2- Annual Quality Program /Review :

Determination of annual quality program based on company Quality program and on line with site objectives. Performing annual quality system review and communicate it with site management.

3- Validation and Qualification process :

Ensures validation and qualification activities (cleaning validation, process validation, equipment Qualification, Analytical validation, Computerized system validation,… etc) are performed according to their respective directives and requirements. Approval of validation / Qualification protocols & reports.

4- Handles External Auditing ( external Manufacturing or local regulatory audits) :

Coordinates & attends external audits performed by regulatory authorities or External business partners, follow up the documentation of the auditors report & the implementation of the corrective actions. Conducts & attends periodic audits of Toll manufacturers and Monitors the implementation of the relevant corrective actions.

5- Self-inspection for GMP related activities among all company departments :

Approval of the annual plan for internal audit for different departments. Follow up the implementation of the audit plan and its corrective actions plans progress.

6- Starting Materials /Packaging materials supplier Approval :

Ensure Supplier of starting and Packaging materials are Qualified and approved and are recorded in Quality third party database. Coordinates with purchasing department the approval of new supplier qualification to ensure continuous and reducing cost while applying sanofi requirements.

7- Follow up the implementation of Global Quality Documents :

Follow up the implementation of sanofi GQDs through gap analysis and determination of resources needed for the implementation.

8- GMP Training Programs and Personnel Development:

  • Ensure that GMP Training programs are on site and managed according to company directives and covers training needs.

  • Approval for the annual GMP training plan.

  • Prepares in co-operation with HR personnel development plan for QO personnel to improve their capabilities and developing Skills

9- Investigations of Failures / OOS:

Final approval of investigations affecting product quality (Failure investigations, Out of specifications) ensuring the root cause identification, corrective actions and preventive measures needed to prevent re-occurrence. Follow-up the implementation of CAPA ( Corrective actions / Preventive actions) determined during investigations and deviations through Quality Assurance. Approval of re-working / Re-processing procedures after the assessment done by QA /QC.

10- Change Control System:

Final Authorization of any change in established procedures and specifications after the evaluation done by QA / QC.

11- Management of product technical complaints/ Recalls:

Ensures presence of system for proper Investigation of technical complaints by QA and approval of final reports Final decision of product recall and follow up implementation of Local recall committee decision.

12- Approval of Master documents / SOPS:

Final approval of all Master documents related to operations such as Batch manufacturing records, methods of analysis, stability protocols and reports, validation documents, etc to ensure adherence to registration, company standards and GMP. Integration and final approval of all interdepartmental functional SOPS to ensure compliance with GMP requirements .Approval of Operational SOPs is delegated to QA manager.

13- Quality KPIs :

Establishment of appropriate Quality KPIs. Preparation of quality KPIs determined by company and reporting them in due time.

  • 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.

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 Pharmacy

Related Experience:

  • Minimum of 12 years experience in pharmaceutical industry of which at least 3 years in Managerial Quality position

Special Knowledge/Skills:

  • Knowledge of GMP regulations

  • Knowledge of local MOH regulations

  • Leadership, Good communication skills

  • Problem solving skills

  • Statistical knowledge

  • TQM tools

  • Computer skills

  • Good command of English language, Preferably and French

  • Good Financial commands

  • feeling of importance of fulfilling market needs

Play To Win Behaviors:

  • 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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.