Offers “Sanofi”

Expires soon Sanofi

Quality Specialist

  • Internship
  • جدة, السعودية
  • Project / Product management

Job description



Quality Specialist for Saudi National only

.         JOB PURPOSE:

·   Support the CQH in the management and the implementation of the Country Quality System across the Commercial entities, embarking all concerned Country functions (responsible for GxP and health-regulated activities), ensuring safe, efficient, quality products, information & services are made available to meet patients and customers’ needs.
·  The Country Quality System management includes the following main aspects:
·  Identification in each function of operational processes that are GxP and health-regulated
·  Ensuring operational GxP processes are fit for use and embed required quality aspects
·  Development/update of Quality Documents related to operational GxP processes
·  Ensuring use of required tools (including  GxP validated Computerized Systems) 
·  Data integrity
·  Quality Risk Management
·  Country Audit & Inspection readiness
·  Qualification and quality oversight of GxP Third-Parties used across country
·  Knowledge management system: training requirements (training curriculum per key job role) and monitoring/recording of execution
·   Deviation & CAPA management with the necessary follow up for CAPA effectiveness
·  Continuous improvement
·  GxP processes  monitoring / measurement / metrics     

KEY ACCOUNTABILITIES

Quality of Country Office Operations (“Commercial Quality Operations”)

Country Quality System .

• Act for implementation & maintain a local quality system including the associated processes, documentation applying to all the affiliate GxP and Health –regulated activities, distribution and marketing of all products developed and/or marketed in the country by Sanofi or through partnership agreements, in compliance with Quality reference standards (internal & external), while meeting business objectives, involving well identified experts in all concerned functions,

• Manage local Quality Documents (QDs) issued by each concerned country office function through an appropriate country office QD management system for GxP and related Health-regulated activities.

Overall

•     Bring Quality insight into the Governance and ways of networking in place in the country office as directed by CQH.

•    Provide guidance to country office functions for the development and management of local    Quality Documents and related required trainings for all staff operating GxP regulated activities.

·  Liaise with HR function to ensure the availability of administrative records for regulated positions (updated CV/job description/training log and updated Organizational Chart)
·  Support to CQH as the country office focal point for Quality Risk Management (identification, anticipation & assessment of quality risks, development & implementation management of appropriate actions plans)
·  Ensure quality oversight of locally managed third-party suppliers/subcontractors for all GxP and health-regulated activities through an appropriate coordination with the concerned global & local function as appropriate
·  Monitor and support the reporting, in collaboration with relevant functions, relevant Key Quality Performance Indicators

Audits/Inspections

·  Liaise with each concerned country office function to ensure continuous audit/inspection readiness by ad hoc connections with the expert groups in charge.
·  Ensure management/coordination of inspections by Regulatory Authorities, with contribution & collaboration of relevant functions at the country level Support  Root Cause Analysis, CAPA definition and follow-up of audits & annual quality review of the country office GxP processes, activities and systems

Quality Reviews

liaise  with other function to carry-out periodic (once annual as a minimum) Country Quality Reviews CQR (meetings)

QUALITY OF PRODUCTS

Product Technical Complaints (PTCs).

·  Manage PTCs received by the country office according to defined Quality Standards & processes and using global Sanofi complaints databases
·   Update PTC tracker timely as appropriate.
·  Coordinate with PV unit for PTC/PV reconciliation process

 Quality events

·  Manage product-related quality events (quality alerts/ recalls/ notifications to & from local Health Authorities) according to defined Quality Standards & processes in networking connections with local functions.
·  Provide Quality input within the country office in case of Product Alerts and/or Crisis Management.

RECOMMENDED NETWORKING DEPENDING ON THE COUNTRY OFFICE SITUATION

Country Quality  Operations (“Commercial Operations”)

·  Animate a network of professionals throughout the Country Office Units/Departments in a matrix environment empowered to address all matters related to Quality (e.g. local QDs, training, administrative records, CAPA management, etc.), with a periodic reporting of Quality outcomes to CQH.
·  Quality oversight for locally managed third parties as required by quality management e.g. key local suppliers, subcontractors, contract manufacturers…..etc.
·   Provide Risk Management expertise to other country office functions as appropriate when needed.

Quality of products

·  Provide Quality support to anti-counterfeit process and activities, through coordination with the local responsible Anti-Counterfeit Coordinator and management of parallel trade issues.
·  Supply chain quality in term of temperature excursion management temperature monitor reading, and control & release of products from a temperature reading point of view.

Education:

Degree in pharmaceutical science (Pharmacist) with diversified experiences in Regulatory, Medical affairs, Quality and/or any other pharma domains

Experience & knowledge:

Minimum of 1-2 years of experience in Medical affairs, Regulatory Affairs, or Quality Assurance.

Knowledge and practical experience of Good Manufacturing Practices (GMP). Ideally worked within a GMP environment in a Quality or Compliance role.

Technical Competencies

·  Knowledge of relevant Regulations, Guidelines, Good Practices, national, regional and international applicable to affiliate operations.
·  Proper understanding of situations requiring issue resolution & capacity for problem solving
·  Provision of general guidance & education (Quality System , Quality Risk Management & PTC management)
·  Easy & quick adaptation to variable situations requiring analysis, evaluation and constructive thinking.
·  Ability to work transversally in a matrix organization & to foster a process simplification approach while meeting compliance requirements.
·  Ability to clearly communicate in English (oral, written)
·  Auditor qualification (preferred)
·  High competence in use of Microsoft Office applications (Word, PowerPoint, Excel)
·  Familiar with Problem Solving and Root Cause Analysis tools (preferred)

Behavioral Competencies

·  Autonomy with confirmed sense of urgency, priorities & self-control.
·  Pragmatic, strong common sense, well-organized person willing to drive a compliant performance in a framed environment while facilitating operating paths.
·  Open-minded & result-oriented team player.
·  Communication/information skills (towards affiliate Management & Global counterparts).
·  Ability to interact efficiently with Competent Authorities/ Inspectorates.
·  Reactivity and ability to act quickly.
·  Demonstrated leadership skills, with appropriate level of flexibility.
·  Highly developed listening & trust-winning capabilities.
·  Ability to influence & convince others in a non-reporting context.
·  Capacity to efficiently interact at all levels within the country organization.

Core competencies:

      Demonstrates success as a seasoned regulatory and business professional within a Multi-national environment.

Demonstrates excellent knowledge and practice in the regulatory field.  Demonstrates capacity to learn and understand business, legal, financial and human resource issues and their impact on the regulatory function. Able to lead by example and foster professionalism in the team through continuous motivation and effective coaching. Highly focused and drives to set for him/herself (and help others to set for themselves) ambitious objectives. Ability to constantly self-challenge and challenge others in a constructive way. Quick to analyze and act without compromising quality; utilizes effective negotiation skills. Shows integrity, tenacity, resilience and adaptability in complex situations and often changing environment; able to handle pressure and commit to and respect deadlines.

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.

Make every future a success.
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