Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MN, Quality Compliance Specialist III R0011539-MZ


 
 

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Job Description

OBJECTIVES:

  • Support Quality Compliance activities associated with Commercial cGMP biologics drug substance operations through internal/regulatory body audits, document review and interactions with site personnel at Takeda Brooklyn Park site.
  • Provide guidance to site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.

ACCOUNTABILITIES:

  • Regularly work cross-functionally with other departments and may also interact with other Takeda sites and/or Brooklyn Park suppliers to ensure global compliance and consistency.
  • Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
  • Conduct analyses of manufacturing-related quality metrics to identify risks, improvement opportunities and/or compliance concerns. Drive resolutions to conclusion by supporting continuous improvement initiatives.
  • Coordinate logistic activities related to the Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.
  • Oversee any required corrective actions resulting from self-assessments or inspection readiness activities.
  • Lead the Inspection Readiness team and support during all internal or regulatory audits/inspections of Quality & Operations departments.
  • Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.
  • Identify and escalate regulatory issues and trends pertinent to Takeda products and business to management, as appropriate.
  • Provide pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).
  • Receive overall project direction from management but completes work independently.
  • Complete mandatory training within required timeframe.
  • Additional tasks and duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor s degree in Life Sciences and 5+ years experience in a regulated industry preferred.
  • Master s degree in Life Sciences with 3+ years experience in a regulated industry a plus.
  • Knowledge of cGMP regulations for US, EU and other markets.
  • Must be detail-oriented and have effective time management skills.,.
  • Excellent interpersonal skills and the ability to work effectively and efficiently in a team environment.
  • Must be able to clearly and effectively present to all levels of the organization
  • Excellent organizational skills
  • Proficientcomputer, verbal and written communication skills.
  • Strong problem solving and data analysis skills.
  • Drives results

PHYSICAL DEMANDS:

  • In general, the position requires a combination of sedentary work and walking around the facility.
  • Frequent wrist and hand motion (e.g. typing, writing).
  • May frequently lift up to 10 pounds (i.e. binders, files)

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, including overnight trips.
  • Requires approximately 0-5% travel.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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