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Employers

QA Manager/Qualified Person, Dublin

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Location:

Dublin, Ireland 

Job Category:

Biotech/Pharma, Science
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EU work permit required:

Yes
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Job Reference:

1757

Job Views:

145

Posted:

11.09.2020

Expiry Date:

26.10.2020
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Job Description:

We are seeking applications for an experienced consultant QA Manager / Qualified Person on a flexible basis, to ensure that licensed Finished Product is certified and released to market in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16. This role requires the successful candidate to be on-site 2 -3 days per week on average.

Why you should apply:

  • This is an opportunity to join a fast moving, rapidly growing entrepreneurial organisation that pursues its mission to transform patients' lives with persistence, dedication and perseverance. We are driven because we know their lives depend on it.
  • If you are Patient focused, like to challenge conventional thinking and enjoy collaborating to solve complex problems – then this is the company for you.

What you will be doing:

  • Own GDP processes and procedures applicable to multiple entities/markets. Collaborating with RPs and equivalent Country Quality Managers, drive continuous improvement and harmonization/optimization of processes / procedures.
  • Principal certification of batches of products prior to use in clinical trials and prior to release for sale and placing on the market.
  • Provide quality and compliance guidance on all critical and major quality matters.
  • Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
  • Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective
  • Review and approving of APQRs as required
  • Provide audit support as required for internal auditing program and supplier audits.
  • Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice

What you need to apply:

  • Bachelor’s degree required; preference given to candidates with advanced degrees
  • Eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
  • Must have a minimum of 1 years’ experience acting as a Qualified Person
  • Minimum 5 years GMP related experience in biopharmaceutical / pharmaceuticals.
  • Eligible and demonstrated ability to act as Qualified Person within EC/EEA, must have a minimum of 1 years’ experience acting as a Qualified Person.
  • Detailed experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
  • Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.
  • Extensive demonstrated pharmaceutical quality experience.
  • Must have thorough knowledge of biopharmaceutical / pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
  • Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
  • Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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