Job Details

City:
Phnom Penh
Job Location:
Cambodia
Contract Type:
Full time
Job category:
Quality Assurance

Company Details

Company industry:
Biotechnology / Pharmaceuticals
Company Type:
Employer (Private Sector)
No. of Employees:
51-100

Preferred Candidate

Degree:
Bachelor's degree
Minimum years of experience:
2-5 years

Professional Skills

Language Skills

Job Description

  • Co-operate with the person in charge of managing quality documentation to develop local SOPs in compliance with Global Quality directives and guidelines and local regulatory.
  • Perform inspection readiness, in particular through the use of the Inspection Readiness Tool (once a year) for Affiliates
  • Support Sanofi auditing groups in the preparation, conduct and follow-up of affiliate quality audits
  • Organise training sessions or programs related to processes owned by the Quality team for concerned country associates, according to Sanofi standards and regulatory requirements.
  • Co-operate with CQH to manage CAPAs related to GxP and health-regulated activities across the affiliate in a consistent manner, and train concerned affiliate associates accordingly.
  • Follow the process to manage the changes that may impact GxP or health regulated process or operations by leading multidisciplinary exchanges and action plans when necessary.
  • Follow  an annual quality program endorsed by senior management across the affiliate
  • Ensure that performing GxP operation complies with valid and signed quality agreements (with Sanofi manufacturing sites, distribution centers as well as with any third party sites) for all GDP/GMP activities under the responsibility of Quality within the country organization.
  • Ensure that valid and signed service agreements containing quality
  • dispositions and other mandatory quality related clauses are in place for all subcontractors of GxP and health-regulated activities
  • Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in the selection process, qualification and performance of audits) or through coordination with the concerned country functions (as appropriate).
  • Take part Quality Risk management process within the country (identification, assessment, control, communication).
  • Provide risk management expertise to other country functions as appropriate.
  • Monitor the events occurring at the affiliate according to defined processes and standards.
  • Inventory computerized systems in use within the affiliate for GxP activities are in compliance with regulations and standards

Position Requirements

  • Degree in medical doctor or pharmacy
  • Minimum of 2 years of experience in Quality Assurance or Regulatory Affairs
  • Experience in Quality Assurance is a plus
  • Knowledge of relevant Regulations, Guidelines, Good Practices, both national, regional and international applicable to affiliate operations
  • Knowledge of Quality Management standards (e.g. ISO)
  • Proper understanding of situations requiring issue resolution & capacity for problem solving
  • Provision of general guidance & education (quality System & QRM approach)
  • Easy & quick adaptation to variable situations requiring analysis, evaluation and constructive thinking
  • Ability to work transversally in a matrix organization & to impulse a process simplification approach while meeting compliance requirements

More information please follow the link below

https://sanofi.wd3.myworkdayjobs.com/en-US/SanofiCareers/job/Phnom-Penh/Affiliate-Quality-Manager_R21942-1

About the Company

Sanofi (Cambodia) Co., Ltd., formerly known as Roussel Cambodge Limited is a joint venture between Sanofi-Aventis Participation S.A.S.,a company incorporated in France.

Sanofi (Cambodia) has been operating in Cambodia since 1993 and has grown rapidly, and has become one of the leading pharmaceutical and vaccine distribution companies in Cambodia.

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