Covance

  • GMP QA Officer I

    Job Location(s) UK-Harrogate
    Job Number
    2018-19920
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    Quality Officer I - 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 I to help support the team.

     

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

     

    About the Job

    The role is a trainee position; therefore, the following duties will require training/supervision:                                                             

    • Preliminary review of site quality documents (SOPs, Policies, etc) for compliance with GMP, Covance document management procedures and other applicable quality standards
    • Performs a preliminary regulatory review to provide recommendations regarding the compliance status of study related documentation (i.e. protocols, reports, certificates of analysis, etc) prior to QA approval
    • Supports the GMP QA internal audit programme by participating as trainee in audits of GMP-related systems, processes and facilities
    • Participates in projects as trainee to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified
    • Review of metrology methods and specifications for accuracy/relevance and compliance with appropriate standards
    • Participates as a trainee in investigations (deviations, OOS, customer complaints, etc) assisting senior GMP QA personnel to assign cause and resolution of quality defects
    • Delivery of basic GMP training
    • Participates as a trainee 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
    • Basic Awareness 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

     

    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 minimum of a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

    Experience

    • A minimum of 5 years’ operating in a non-GMP Quality Assurance role within the Pharmaceutical Industry
    • Basic Awareness 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

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