Life Sciences Jobs

Jump back

QA Lead – Drug Substance / Drug Product

Type Permanent

Salary Negotiable

Location Louth

Ref # 8423

Apply now!

Barden are delighted to be supporting our client in their search for QA Lead. Our client is a premier provider of vaccine services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They are one of the world’s top three contract development and manufacturing companies for biopharmaceuticals.

 

ABOUT THE ROLE:

You will be responsible and accountable for ensuring GMP production quality system in place adhering to all regulatory, cGMP and company requirements. Ensure all structures are in place to monitor, measure and ensure successful programme is applied.

Your Responsibilities:

  • Act as site QA responsible for on-site quality monitoring of DS/DP manufacturing and participant in GMP production activities, such as process transfer, validation etc.
  • Close monitoring the construction quality of GMP production.
  • Support CQV activities as necessary.
  • Work with functional department to create department SOPs and assure alignment with corporate policies.
  • Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective.
  • Support site GMP Readiness preparation activities, including internal self inspection programme.
  • Work closely with other team, to support all GMP production activities.
  • Perform routine audit for manufacturing area, to assure GMP production in compliance with all regulatory, market, EU, FDA and company standards.
  • Review and approve manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc.
  • Ensure accurate reporting of Manufacturing generated results and assure data integrity in daily activity.
  • Responsible for managing a team of employees across QA for DS/DP. 
  • Ensure all associated performance management requirements are in place for each employee and relevant reviews are completed regularly.
  • Liaise actively with cross functional teams for release DS/DP, including preparation of all documentation necessary for QP release.
  • Delegation of responsibilities to Sr. Specialist, QA for DS/DP

 

ABOUT THE PERSON:  

 

The ideal candidate for this position, will have the following:

  • Bachelor of Engineering or Science Degree in Engineering, Quality or Technology related discipline
  • Knowledge of legislative, regulatory, market, biologics and data integrity requirements.
  • Preferable to have qualification Degree in Biopharmaceutical Science or other related science discipline.
  • Relevant experience in vaccine/bio-pharma or similar experience in a pharma/science background.
  • Strong communication skills with demonstrated ability to work in a matrix environment. 
  • Strong leadership competencies with demonstrated 5+ years management experience.

Hi, we’re Barden.  We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.

Apply now to this job

Working with Aidan’s team

Aidan Crowley leads a team of life sciences talent advisory and recruitment experts that work exclusively with life sciences professionals across Ireland. With a deep understanding of leading businesses, team structures and cultures, Aidan and his team go to great lengths to provide a consultative and supportive services to the talent they work with. Aidan and his team are where life sciences professionals go for advice before they start looking for a job.

    Apply with your CV

    By submitting your CV application you consent to your data being used as outlined in our Privacy Policy.

    Thank you for applying to this job

    Thank you for your application. One of our expert team will be in touch in due course. In the meantime please do continue to browse our open assignments or check out some of our expert Life Sciences insights in our resources area.

    You might also like

    Quality Specialist

    Cork (All)

    Negotiable

    View Job

    Principal QA Representative API - EM

    Cork (All)

    Negotiable

    View Job

    Senior Microbiologist

    Limerick

    Negotiable

    View Job
    See All Related Jobs