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    Job · 19224825

    Syneos Health logo

    Sr Professional Quality Managament (GCP)

    Syneos Health · Hyderabad · onsite · Posted 27d ago

    Undisclosed4–8 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Sr Professional Quality Managament (GCP Exp Required)

    Job Summary
    Performs various activities (analysis, investigation, reporting, administration) related to GCP (ieie Good Clinical Practice or Good Pharmacovigilance Practice) and related topics for Clinical departments.


    Core Responsibilities
    • Supports Clinical Monitoring (CM) teams through the duration of sponsor site audits
    • Work with CM teams for the preparation of site audits, which includes performing quality checks on training documentation/TMF/study documents.
    • Assist and work with CM teams during Audits and Inspections to determine underlying Issues, perform Root Cause Analysis (RCA), formulate appropriate Corrective and Preventative Actions (CAPAs), and implementing Effectiveness Checks
    • Provides quality support and consultancy for Quality Management andfor Operations, as applicable
    • Works within a specific knowledge area. May work outside area.
    • Ensures commitments and timelines for assigned activities adhere to Syneos Health and customer requirements.
    • Offers solutions to process and quality related issues and identifies process improvement opportunities
    • Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
    • Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
    • Solves moderately complex problems and/or conducts analyses. Translates concepts into practice.
    • Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
    • Serves as a key resource within a business area or discipline.
    • Anticipates and resolves problems, which may be moderately complex. Applies critical thinking to identify solutions to requests and problems
    • Drives solutions for products, processes, and services
    • Leads medium-scale Quality Management projects or programs with moderate risks and resource
    • Normally receives little instruction on day-to-day work, general instructions on new assignments
    • Represents Quality Management, as assigned
    • Performs other quality-related activities as directed by management
    • This position is not responsible for supervising employees
    • Travel may be required (approximately 15%)


    Qualifications
    • BA/BS degree in science or health care or equivalent education and experience, plus some experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) preferred.
    • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.
    • Above average attention to detail and accuracy.
    • Strong organizational, interpersonal and team-oriented skills.
    • Ability to act independently and pro-actively.
    • Significant project management and customer management skills.
    • Ability to perform several tasks simultaneously to meet deadlines.


    Disclaimer
    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    Good Pharmacovigilance PracticeAgiledrug developmentline managementgoogle cloud platformbsauditscustomer successCustomer ManagementGood Laboratory Practiceclinical monitoringHealthcareManufacturingAdministrationcomplianceLife Sciences

    About Syneos Health

    Syneos Health logo

    Syneos Health

    Clinical Research

    3.3k+

    employees

    1984

    42 years old

    Hyderabad / Secunderabad, Telangana

    India

    About

    Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.

    Industries

    Clinical ResearchBiotech & Life sciencesAnalytics & KPO

    Employee ratings

    813 reviews

    3.6/ 5

    Culture

    3.5

    Career growth

    3.0

    Work-life

    3.7

    Employees rate it well for

    Work Life Balance184Work Culture94Salary76Senior Management70Career Growth49

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