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IA-QA Specialist-Beijing

date publiée 10/13/2021
type de contrat Full time
reférence de l’emploi R2614870
location Chine

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

- Set clear direction & aligns team & others, around common objectives

- Inspire continuous improvement & breakthrough thinking,display analytical &conceptual thinking

- Have broad presence and resources within large platform to boarden globlal view sight

What you can contribute?

Providing quality oversight for GMP pharmaceutical product manufacturing related activities

  • Review routine manufacturing, environmental monitoring and quality control data for in-process and finished products; review and record all batch related documentation timely, assist in release of finished product and ensure that following requirements have been met
  • All the necessary checks and tests have been performed
  • All necessary production documentation has been completed and endorsed by qualified personnel and is in compliance with Sanofi quality policy, local regulatory and GMP requirements
  • Changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any products is released
  • Provide quality assurance oversight by performing routine walk-throughs and inspections on Production, Engineering, Supply Chain and other areas assigned where the business is responsible to ensure that all aspects of operations comply with cGMP legal and regulatory requirements as well as Global Guidelines. Escalate timely, follow up and support the completion of related actions
  • Lead deviation investigations by demonstrating a high level of independent judgment and discretion in the timely identification, investigation and resolution of deviations potentially impacting the quality of products and processes; provide support and advice during cross functional investigations and when required; participate in devising sampling procedures and directions for recording and reporting quality data; review deviation reports and ensure investigations were performed in accordance with established procedures and GMP requirements, and ensure deviations are completed timely .Participate in the initiation of corrective and preventative actions, support CAPA implementation and review CAPA effectiveness
  • Lead product quality review and ensure the PQR is completed following relevant procedures and GMP requirements timely
  • Developing, implementing and maintaining the corporate Quality Management System
  • Complete personal trainings according to individual annual training plan and other training requirements. Conduct training in aspects related to pharmaceutical product manufacturing, Quality Management Systems and GMP
  • Draft, review and revise SOPs and any other site/product related documents ensuring adequate levels of documentation and compliant to existing procedures
  • Participate in regular quality audits of the site; support on-site audits conducted by external providers; evaluate audit findings and participate in the implementation of appropriate corrective actions
  • Participate in qualification and validation management activities, including those covering equipment, processes, methods, and API/excipients/primary packaging materials/critical supplies specifications etc.; review related documents. Support the review and implementation of Change Controls
  • Complete other duties as designated by the superior

Quality Department HSE Responsibilities

  • Responsible for following the company’s HSE policy,and integrated all requires into daily job.
  • Incorporate HSE work into the work plan
  • Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
  • Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
  • Timely working out of employee opinions.
  • Actively cooperate with HSE management to prevent accidents happens.
  • Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
  • Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
  • Responsible for design annual department PASS plan, and ensure implementation as planned.

Quality Department Energy-saving Responsibilities

Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

  • Actively propose energy-saving projects
  • Coordinate and support the development of energy-saving projects and give positive feedback
  • Coordinate and participate in the implementation of energy-saving projects
  • Participate in internal audit of energy management system

What you should have?

Education / Experience

  • At least a bachelor’s degree in pharmacy, chemistry or biology disciplines with minimum 3 years’ experience in drug quality control and /or quality assurance
  • Knowledge of analytical chemistry and/or microbiology prefer

Technical skills &Competencies / Language

  • Must be a committed “quality” professional with knowledge of regulated quality systems within the pharmaceutical or related industry
  • Knowledge of Chinese pharmaceutical rules is mandatory as well as basic knowledge of international GMP
  • Good command of written and spoken English

Behavioral Competencies

  • (LEAD and others)      Good communication skills
  • Stress tolerance

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

  • Exercise good judgment & drives change for competitive advantage
  • Drive for superior results & has passion to win
  • Build the talent pipeline and develop others
  • Able to burden pressure, result driven

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.

Veuillez noter que vous quittez les pages d'entreprise de Sanofi et que vous êtes redirigé vers notre système de suivi des candidats, Workday, qui vous permet de postuler à nos postes vacants.

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Veuillez noter que vous quittez les pages d'entreprise de Sanofi et que vous êtes redirigé vers notre système de suivi des candidats, Workday, qui vous permet de postuler à nos postes vacants.

Continue