Covance

  • GMP QA Officer II

    Job Location(s) UK-Harrogate
    Job Number
    2018-19916
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    Quality Officer II - GMP

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

     

    We are recruiting for our Early Development Chemistry team in Harrogate and are currently seeking to hire a Quality Officer II  to support the team.

     

    This is a full time position, based in our Harrogate office.

     

    About the Job

    Within this position, your duties will include:

    • Reviews and approves departmental quality documents (SOPs, Policies, etc) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
    • Performs regulatory review of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc)
    • Supports the GMP QA internal audit programme by participating in audits of GMP-related systems, processes and facilities
    • Review of metrology methods and specifications for accuracy/relevance and compliance with appropriate quality standards
    • Approves deviation investigations and CAPA (addressing the cause and resolution of quality defects)
    • Supports root cause investigations/ risk assessments
    • Participates in projects providing recommendations to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified
    • Monitors the effectiveness of the GMP Quality Management System and provide trend data for input into the Management Review Process
    • Contributes to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations

    What we’re looking for

    To be successful in this position, you will need to hold a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

     

    Additionally, you will need to demonstrate:

    • A minimum of 5 years’ operating in a GMP environment or in a non-GMP Quality Assurance role within the Pharmaceutical Industry and a minimum of 1 year in a GMP Quality Assurance role within the Pharmaceutical Industry
    • In depth knowledge of Good Manufacturing Practice Regulations
    • General awareness of industry quality systems/standards, e.g. ICHQ10                              
    • Good communication, decision making, negotiating, and problem solving skills
    • Experienced Auditor
    • Experience in process improvement preferable
    • Ability to work under minimal supervision
    • Computer literate

    Get to know Covance

    Covance, the drug development business of LabCorp, is the world’s most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team’s impact on healthcare is remarkable. Through their everyday work they’ve supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

    The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you’ll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you’ll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

    Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

    EEO Statement

    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

     

    Education / Qualifications

    • A Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

    Experience

    • A minimum of 5 years operating in a GMP environment; at least 1 years’ experience in GMP QA
    • In depth knowledge of Good Manufacturing Practice Regulations
    • General awareness of industry quality systems/standards, e.g. ICHQ10                              
    • Good communication, decision making, negotiating, and problem solving skills
    • Experience in process improvement preferable
    • Ability to work under minimal supervision
    • Computer literate

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