Junior Qualified Person

  • Permanent
  • Location: Offaly
  • Ref: 917432

Job Details

Return to Search Jobs

What you need to know

Matrix Recruitment Group are currently recruiting for a Site Compliance and Product Release Senior Specialist / Qualified Person for our client in the Pharmaceutical industry based in Offaly.

Your new job

  • Support the implementation & continuous improvement of an effective quality management system including quality oversight across the site
  • Assume an active role in the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions
  • Review & approval of batch records and associated raw data for manufacturing operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process
  • Participate in and support Site License registration process and future license updates
  • Review of analytical data and associated reports
  • Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions
  • Perform batch review and approval of investigational veterinary products and commercial products
  • Participate in or lead internal and external audit including 3rd party audits and supplier reviews
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved
  • Initiate and implement change control activities in accordance with site procedures
  • Assist with oversight of issue management and non-conformance events to ensure compliance and timely closure
  • Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
  • Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement
  • Write or assist in writing, reviewing and approval of SOPs and other GMP documents
  • Develop and where appropriate deliver training across the teams regarding the quality topics and metrics

What are we looking for?

  • BSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) and be QP qualified.
  • At least 5-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.
  • Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
  • Experience of interaction with cross functional departments.
  • Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.
  • Ability to support relevant sections of CTD for regulatory submission.
  • Excellent interpersonal and communication skills, meticulous eye for detail.
  • Self-motivation.

    Apply for this job now via the link below

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given. 

We Value Your Trust.

    *
    *
    *
    *
    *
    *
    *




    Alternative Text

    Recruitment Consultant: Joanne Foley

    Job Categories:

    Not the right job for you?

    Don’t worry we have plenty of other jobs that you might be interested in. Click the button below to get in touch with us for a confidential chat.

    Get in Touch