Quality Compliance Vietnam Lead

2 weeks ago

Ho Chi Minh City, Ho Chi Minh, Vietnam Adecco Full time

Responsibilities:

  • Be responsible the tactical translation and execution of the Quality and Quality Compliance strategy, which includes:
  • Ensuring all external (GMP, GDP) and internal company requirements (Policies, OCS, OCP, and, ACP) are implemented
  • Monitoring and improving performance adherence
  • Ensuring appropriate Quality oversight.
  • Be responsible for the External Service Provider Management, which includes:
  • Ensuring GMP/GDP and regulatory compliance of products/services which are outsourced to external parties
  • Operating/acting in the capacity of a key quality contact for assigned suppliers/external partners (including QAA negotiation and maintenance, audit management, complaints processing, assessment of deviations, CAPA management, change control, vendor rating and project support), establishing and maintaining effective quality systems and procedures in accordance with company requirements
  • Establishing and maintaining contact to relevant quality management with suppliers/external partners, ensuring seamless and proactive communication and collaboration and align processes between company and supplier/external partner
  • Supporting GMP/GDP audits at local suppliers and external partners (qualification and regular audit), supporting the annual audit plan and followup on CAPAs resulting from audit findings
  • Be responsible for internally managing the Quality System Management
  • Documentation Management, which includes:
  • Ensuring the set up and maintenance of a document management system for local SOPs/Working Instructions (archiving, distribution, access, revision)
  • Ensuring that applicable Corporate Procedures are transferred into local SOPs/Working Instructions
  • Ensuring that training on SOPs/Working Instructions is properly performed and documented
  • Analyze any significant changes in the GMP/GDP environment and identify need for SOP/Working Instructions writing and/or communication to ROPU QCO on any local Regulatory changes
  • Be responsible for internally managing the Quality System Management
  • Operations Regulatory Intelligence (ORI), which includes: maintaining a library of all the relevant regulations and guidelines related to commercial product supply and distribution such as GMP, GDP and if applicable local regulations regarding cosmetics, food supplements or medical devices.
  • Be responsible for internally managing the Quality System Management
  • Audit Management, which includes:
  • Ensuring regular self-inspections to drive the continuous improvement program and to ensure readiness of the corporate for Corporate or Authority inspections
  • Managing audits by Corporate or inspections by local Authorities in respect to GMP/GDP
  • Ensuring adequate CAPA plans are established and tracked for completion.
  • Be responsible for training, which includes: identifying training needs and coordinating/performing all facets of GMP/GDP training (introduction and ongoing) inclusive buildup of Quality Culture within the organization.
  • Be responsible for Product Supply Support
  • Be responsible for Project Support
  • Be responsible for Quality oversight
  • Be responsible for Deviation/CAPA Management

Experience requirements:

  • Experience in the pharmaceutical industry preferably with the working experience in the FIE pharma company
  • Must have significant experience in a GxP regulated environment with extensive specialized QA knowledge.
  • Thorough knowledge of GxP/ Quality regulations and compliance regulations with practical expertise in QC/ QA/ Manufacturing in pharmaceutical/ vaccine industry
  • Excellent oral and written communication skills both in native language and in English language
  • Communicates effectively results and project status both internally and externally
  • Prepares technical reports incl. audit reports, executive summaries and management presentations
  • Demonstrates strong analytical skills, is able to judge when more information is needed, where to obtain it and to draw sound conclusions from available information
  • Demonstrates mature judgement and strong decision making skills regarding project and product issues
  • Recruits, develops, coaches and executes performance management for assigned staff
  • Demonstrates a commitment to quality in all work. Sets high goals for standards, performance for oneself and others. Plans, does, checks, acts
  • Good negotiation and effective influencing skills. Develops and maintains constructive relationships internally and externally
  • Must possess strong organizational, analytical and problem solving skills
  • Willingness to travel
  • Ability to appropriately balance compliance and business needs to ensure problems are identified, clearly articulated, escalated and resolved with the right sensitivity to timing, risk consideration and overall business impact

Education requirements:

  • Bachelor degree majoring in Pharmaceutics/ Biology/ Chemistry

Contact Person:

Linh Hoang

Adecco

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