Merck

(高级)质量验证顾问 (BB-E4B19)

Found in: Neuvoo CN

Description:

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role:

The candidate will be a key quality & regulatory expert for biopharmaceutical development and manufacturing to provide consultancy service to customers. The candidate should have understanding of regulations relevant to vaccine, mAb, and other biologics and sterile drug manufacturing and biopharmaceutical processing include upstream, downstream and formulation and final filling. In addition, the candidate must be well-versed in regulatory trends, aligned with the strategy of Life Science to build regulatory expertise relevant to Biopharmaceutical regulations. The candidate will maintain validation procedure, assure validation requirement meet compliance requirement and global policy requirement. Responsible to draft required validation protocol, validation report, organize and execute validation activities as per customers’ requirements. Organize the investigation for validation event. Maintain the validation schedule; assure to execute all kinds of revalidation activities timely.

Key Job Responsibilities:

  • Provide consultancy services to pharmaceutical companies for GMP/cGMP compliance.
  • Provide relevant training to customers about new regulatory trends and developments.
  • Take active role to build regulatory intelligence and surveillance. Focused area includes single-use, aseptic processing, virus validation, process materials and microbiological & analytical testing.
  • Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations. Increases the influence of in important regulatory bodies and industry associations.
  • Effective coordination of strategic activities of LS Quality/Regulatory/Technical subject matter experts in local regulatory bodies and industry associations.
  • Training for and support of internal stakeholders, external customers and relevant regulatory bodies.
  • Facility and Utilities System Validation. Responsible for performance qualification for water system, clean steam system, HVAC systems, Compressed air system, facility system after change happened and when it is necessary.
  • Equipment qualification. Responsible for performance qualification of new equipment and changes for old equipment if necessary.
  • Computerize System validation. Responsible for validation of software related quality system.
  • Who you are:

    Education and Languages:

  • Master in life sciences or related science/engineering background with a strong emphasis in biologics.
  • Fluent in Chinese & English (verbal and written) is required.
  • Professional Skills and Experiences:

  • Minimum of 10 years of relevant industry experience and/or quality & regulatory related to biopharmaceutical products, pharmaceutical substances and process materials.
  • Knowledgeable of NMPA drug regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
  • Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures.
  • Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene therapy).
  • Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.
  • Experience working in a global, matrix environment.
  • Personal Skills and Competencies:

  • Strong organizational and time management skills.
  • Good project management skills.
  • Ability to train and educate others.
  • Effective management by influence.
  • Some experience in thought leadership.
  • Ability to work in multi-cultural teams.
  • Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
  • Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
  • Ability to indirectly influence other organizations and cultures.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
  • Able and willing to travel frequently
  • HR: 89829

    Functional Area: Regulatory Affairs

    What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

    calendar_today3 days ago

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    info full-time

    location_onShanghai, China

    work Merck

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