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Not Disclosed by Recruiter Posted 59 days ago Job Applicants: Less than 10 Job Views: 65

Job Description

 
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    Validation Project Manager will interface with our clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
    This role may also support the development and execution of validation scopes such as FATs, SATs, CTPs, IQs, QoS, PQs, PVs, and other validation lifecycle documents.
    The Validation Project Manager will be responsible for developing project scope statements, estimates and proposals.
    This role may also assist in the development of policies, programs, and project master planning.
    This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
    Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
    Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
    This position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
    A working knowledge of, and experience generating life cycle documentation such as URSs, FRSs, and SDSs.
    Required experience with good documentation practices, cGMP, & FDA CQV methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
    This position also requires a working knowledge of pharmaceutical and biotechnology systems, as the role will involve identification, interface, and operation of this equipment.
    Project Management Professional (PMP) certification is desirable.

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Production , Manufacturing , Maintenance

Role Category:Senior Management

Role:Head/VP/GM-Regulatory Affairs

Employment Type: Permanent Job, Full Time

Keyskills

Desired Candidate Profile

    Please refer to the Job description above

Education-

UG: B.Tech/B.E. - Chemical, Mechanical, Production/Industrial

Company Profile:

Barry-Wehmiller International Private Limited

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