Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Quality Assurance Validation Sr. Specialist SR0033789-MZ


 
 

Primary Duties

This position provides senior level support of the QA Validation functions for the Massachusetts Biologics Operations with primary support at the Alewife location.

  • Provide quality oversight of facility and equipment commissioning and qualification activities.
  • Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
  • Support cleaning validation efforts.
  • Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
  • Use project management skills to drive results and achieve expected timelines and outcomes.
  • Represent the QA-Validation team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
  • Support regulatory inspections and inspection readiness activities.

Responsibilities

50%

  • Provide quality oversight and ensuring GMP compliance for engineering and validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, engineering design, qualification, process validation and change management.

20%

  • Serve as point of contact for customer groups to identify project needs and ensure practices are consistent with quality and regulator standards.

15%

  • Support site validation maintenance activities and continuous improvement initiatives.

10%

  • Providing support during internal and agency inspections and performing quality assessment for all site based engineering changes.

5%

  • Develop and maintain good working relationships with customer groups and support an environment of teamwork and collaboration.

Education and Experience Requirements

  • 5+ years of industry experience in a pharmaceutical/biotech GMP environment.
  • BS in Engineering and or Science and a minimum of 3 years of project support experience with increasing responsibility in the areas of Quality Assurance.
  • Knowledge of FDA and EMEA regulations, ASTM E2500, process validation, and a working knowledge of statistical analysis and root cause analysis is required.
  • Excellent interpersonal skills and strong oral and written communication.

Other Job Requirements

The ability to work at all MA site locations as required.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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