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 Previous Job   

Senior Compliance Engineer II
Cambridge, MA

Primary Role:

Responsible for managing and execution of QQalCty System Programs applicable to the Facilities Operations function within Shire HGT.
Provides in-house expertise in application of the best industry standards and regulatory agencies requirements to the Facilities operations practices.

Responsibilities:

-Leads GMP investigation, CAPA, and Change Control related activities.

-Responsible for the continuous improvement process of the cGMP documentation systems including regulatory audit readiness.

-Manages materials, parts, and components certification and compliance
process.

-Facilitates compliance of all long term maintenance programs including
Equipment Performance Evaluation, Corrosion Control,
Plant shutdown work, etc.

-Provides in-house compliance expertise to the maintenance crew. Presents for
review, and provides training on the latest industry trends and regulatory agencies
releases.
Requirements
Education & Experience Requirements:
BS degree with extensive experience(minimum of 8 years) within commercial pharmaceutical manufacturing environment is highly desirable.
Key Skills and Competencies:
Good communication skills and ability to provide effective management for several simultaneous projects. Extensive expertise in the area of risk analysis / management, internal quality control procedures, good working knowledge of industry practices, current regulatory guidelines and requirements.
Complexity and Problem Solving:
Makes critical decisions related to all quality and compliance aspects of the Facility Operations activities. Provides recommendations and solutions to complex reliability, compliance, and operational problems. Provides guidance to maintenance personnel and actively participates in the decision making process.
Internal and External Contacts:
Maintains communication with contractors and supply vendors. Actively participates in interdepartmental teams. Effectively communicates with all HGT sites to assure a high level of consistency of facilities and maintenance practices.
Other Requirements:
The ability to work at all Shire HGT site locations. Incumbent will be required to carry a phone / Blackbeny device and be on call as required to support operations.


Last verified - 1 day(s) 3 hour(s) ago   [What does Last Verified mean?]



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