CARBOGEN AMCIS

QA Manager (BB-592FC)

Found in: Neuvoo CN

Description:
  • Main Responsibilities:

    Prepare, review, release documentation for raw materials, intermediate and finished product. Provide QA (and regulatory affairs oversight) for deviations, OOS, change control; prepare and review the regulatory documentation during process transfer; facilitate the enquiries and communication with the Health Authorities whenever needed. Support internal and external audit, assisting in the preparation and smooth execution of audits from Health Authorities, Corporate, and Customer. Support reporting and trending of Quality KPIs on periodic basis as required. Identify and lead continuous improvements initiatives, including workflow processes to improve productivity. Review SOPs, specifications, method of analysis, batch records and other technical document. Provide QA oversight for utility systems, production equipment, warehouse(including raw materials, packaging materials and recovered solvents). Assist Head of Quality Unit in any other duty as required.

    Education:

    Degree in Science (Pharmacy, Chemistry) or related disciplines. Chinese mother tongue, intermediate level in English.

    Experience:

    Minimum 5 years working experience in quality department with good understanding of quality requirements (e.g. FDA, NMPA, EMA, MHRA, WHO) and production processes. Working experience in a GMP environment in Pharmaceutical/ API industry.
  • calendar_today1 day ago

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