QC Lead Analyst OC
Ireland - Dungarvan, Ireland
18d ago

Your Responsibilities : Job Purpose

Job Purpose

To support the QC Team Leader in all activities associated with their quality control stream and ensure all activities comply with all GMP, GLP, EHS and regulatory requirements.

Scope of Responsibility

Headcount Managed (Indirect Reports)

Approx 5-12 indirect reports

Designate for the QC Team Leader. Reference sections below on EHS, Quality and people management responsibilities for full details.

Impact of role on business objectives

  • On time release of raw material and packaging components to the manufacturing and packaging areas to ensure schedule adherence and reduced inventory.
  • On time release of medicinal and medical device products to the market place to ensure customer satisfaction and reduced inventory.
  • Ensure product is tested to GLP / GMP standards.
  • Quality Responsibilities

  • Perform duties in a compliant manner and behave in accordance with site SOP’s, Quality Management System standards and guidelines and relevant legal requirements.
  • Ensure Adherence to all quality standards Lead by Example .
  • Read and understand relevant Standard Operating Procedures, Global Quality Procedures and Management Policies relevant to your job role.
  • Ensure all quality metrics are adhered to.
  • Ensure QC team work in accordance with GLP / GMP standards.
  • Be aware of the impact of your job activities on quality.
  • Training of QC team in accordance with GLP.
  • Review of completed analytical reports prior to OQ approval.
  • Preparation, review and approval of in-house procedures e.g. SOPs, monographs, protocols etc.
  • Troubleshooting analytical problems.
  • Participate fully in our site’s quality initiatives and support quality continuous improvement programmes.
  • Decision-making and liaison with internal departments to gather information in order to disposition product in accordance with GMP.
  • Liaison with corporate colleagues as required resolving issues.
  • Escalating issues to the Quality Control Team Leader / Manager, OQ Manager and Quality Director as appropriate.
  • Scheduling relevant QC function to ensure that the QC team operates as efficiently as possible and product lead-times are maintained.
  • Assist in leading the QC function in preparation for, and during external agency audits and internal GSK audits.
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical device Products / Markets.
  • People Management Responsibilities

  • Excellent communication / interpersonal skills with a strong affiliation with customer support.
  • Assist the QC function in preparation for, and during external agency audits and internal GSK audits.
  • Building capability in Team
  • Drive accountability within the team
  • Must have can do attitude.
  • Problem Solving

  • Ability to think strategically and use sound judgment.
  • A champion of change to improve systems and processes.
  • Play a key role during investigations that have resulted in non-conforming products or compliance failures.
  • Demonstrated ability to effectively plan work and to manage projects.
  • Basic Experience

    3-4 years experience in a pharmaceutical / healthcare industry in an analyst capacity.

    Preferred Experience

  • Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately, e.g. :
  • o ISO 13485 2012

    o QMS GSK Policies and Procedures

    o EU GMP

    o Pharmaceutical Affairs Law Japan

    o CFR 820

    o GSK Facility & Technical Process Guides

  • Understanding of the quality systems for Medical Device and Medicinal Products and an understanding of the relevant regulatory requirements for markets.
  • Knowledge of products and the manufacturing processes for Medical Device and Medicinal products.
  • Expected level of application of Knowledge

  • Good level of knowledge required to understand the production, QC processes and quality systems on site.
  • Ability to provide key input into QC team decisions.
  • The closing date for applications is the 20th of July 2018.

    Basic qualifications :

    Educated to a minimum of primary or higher science based degree level.

    Preferred qualifications :

    Third level chemistry-based degree or associated science (preferably post graduate).

    Why GSK? :

    At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-

    leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.

    To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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