质量部部门经理

Hiring By - Biostaffic

 BioPharma

China

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Responsibilities
  • To supervise the drug manufacture process and quality management system based on Chinese GMP, EU GMP and related ISO standards, and ensure its effective implementation and regulatory compliance.
  • To review and approve quality related documents, including: 1) SOPs and management procedures; 2) Product Manufacture Master Files, including manufacturing formula, processing methods/instructions, quality specifications, testing methods, batch production records, batch packaging records, batch analyzing records, etc.
  • To review and approve the sampling, analyzing and evaluation procedures for raw materials, finished products & semi-finished products.
  • To review and approve the environment monitoring program and ensure its effective implementation.
  • To review and approve the plans, protocols, and reports of validation/qualification & calibration.
  • To review and approve significant deviation reports, change controls, and other related technical reports, etc.
  • To ensure all relevant customer quality complaints investigated/ handled properly, and effective CAPAs established/implemented.
  • To ensure the suppliers evaluated, qualified and audited appropriately.
  • To ensure to provide GMP interpretation and conduct GMP training to employees.
  • To establish regular contact with competent authorities, to receive GMP and ISO certification inspections at all levels, and prepare and implement CAPAs.
  • To supervise the implementation of GMP and ISO standards by all departments and provide guidance. To take charge of management reviews, self-inspections and internal audits, and implementation of relevant CAPAs.
  • to prepare the budget and implement the approved budget, including cost, capex and headcount. To achieve the set KPI targets for QM Pharma department.
Knowledge & Skill
  • Being familiar with the dynamic GMP, ISO standards and other relevant regulations and guidelines, deep understanding of manufacturing processes and quality assurance technologies for Drug.
  • Bachelor’s degree or above, majored in pharmaceutical, chemistry, or science & engineering related subjects, etc.
  • Good English communication skills.
Competence
  • Being excellent at continual learning, knowledge application, interpersonal communication, organization & co-ordination, risk assessment, and handling unexpected events.
  • Engaged in quality management or manufacturing in pharmaceutical industry over 5 years.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • China

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 13, 2024
Company Overview
Morgan Philips Group
Morgan Philips Group

Current Openings: 0

Le groupe Morgan Philips bouleverse les codes de la chasse de têtes, du recrutement et du conseil en gestion des talents en proposant une gamme de services modernes et innovants, conçus pour s’adapter au nouveau monde du travail. Notre approche repose sur un conseil personnalisé associé à notre capacité de recherche mondiale et aux dernières technologies de sourcing. Cette approche nous permet de proposer un ensemble de solutions intégrées comprenant le recrutement de dirigeants, le conseil en gestion des talents, le recrutement temporaire et permanent, l’outplacement et le management de transition.
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