Quality Operations Snr Specialist
Menuma, Saitama, Japan
3 日前

Job Description

Position Overview Basic Functions & Responsibility

Essential function(s) includes, but is not limited to :

This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with our Manufacturing Division requirements and regulatory requirements and expectations.

Under his / her responsibilities fall the quality oversight for

  • Receipt, handling, storage, and disposition of bulk products, raw materials and components
  • Batch record review and Release related to components
  • Deviation investigations
  • Corrective and preventive actions (CAPA) investigation, management and approval
  • Audit Responses
  • The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Operations Manager) with regards to the above described activities.

    The incumbent should lead a team of 4 to 5 members whom responsible for above activities at our site.

    Primary Activities

    Primary activities include, but are not limited to :

    1. Establish adequate controls and procedures for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labeling, drug substances incl.

    intermediates and drug products incl. intermediates.

    2. Ensure that adequate processes and procedures are in place and followed for material release

    3. Lead investigations related to the section with collaboration of other departments as needed. Also generate deviation reports, perform trend analysis of root causes on a periodic basis.

    4. Manage corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labeling, drug substances and drug products and associated facilities.

    5. Perform Annual Product Reviews / Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.

    6. Represent quality, provide quality oversight in complex projects or initiatives such as new product introduction.

    7. Lead the team for continuous improvement initiatives and be act as a change agent to initiate such activities.

    8. Manage Quality and supply KPIs related to the section in aligned with site Hoshin.

    9. Establish skill development schemes for the team, be a part of talent development for the team.

    10.Manage daily activities, issues through standard processes such as Tier.

    Skills (include specific skill levels required to apply our Company's Leadership Principles)

  • Degree in Life Sciences, Engineering or related relevant discipline.
  • Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality (including QC) and / or manufacturing roles.
  • Leadership skills
  • Knowledgeable of Japanese and global authority quality and compliance requirements
  • Knowledgeable in Industry Best Practices for quality and compliance related topics.
  • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
  • Team lead experience
  • Preferably have project management skills.
  • Be ready to act as change agent
  • Good Japanese and English communication skills (TOEIC 750 or more)
  • Search Firm Representatives Please Read Carefully

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

    All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

    No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

    Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    Employee Status : Regular

    Relocation : Domestic

    VISA Sponsorship :

    Travel Requirements :

    No Travel Required

    Flexible Work Arrangements :

    Shift : Not Indicated

    Not Indicated

    Valid Driving License :


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