MV01-022726 Project Change Controls Generation

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Project Change Controls Generation

Description:

• Prior to Change Approval:
  • Conduct meetings with Subject Matter Experts (SMEs) for Change assessments and obtain Change Ratings and a list of required Implementation Steps.
  • Prepare an informal Risk Assessment of the Change with the support of SMEs.
  • Present the Change in the required forums for the "go-ahead" (Quality Board, EHS Board, Process Team Meetings, etc.).
  • Generate the Change in Trackwise, including the creation of Implementation Steps.
  • Follow up with approvers when the Change is in the approval process.
  • Make corrections to the Change based on approvers' feedback.
• After the Change is Approved:
  • Prepare Reports (e.g., Change status reports, Implementation Steps, etc.).
  • Follow up with Executors for Step completion.
  • Generate Amendments and Extensions as necessary.
  • Attending Project meetings as required.
  • Hold meetings with SMEs during the execution of the Change to clarify Step details, such as the evidence required for Step closure, etc.
  • Conduct meetings with the Change evaluator when Steps have been closed to ensure that all activities have been executed successfully.
  • Provide support for closing Steps that are pending during the final stage. This may sometimes include Step execution.
  • Assignment and execution of Steps (depends on the expertise required for execution and access needed to complete the Steps).
  • Procure documentation for Step closure and close the assigned Steps.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.