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May 22 2018

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Job Offer: Qualified Person - Biologics / Steriles:Clarity Recruitment

Job description:

Qualified Person - Biologics / Steriles

Clarity Recruitment


   » Dublin
   » 70000 - 80000
   » Permanent full-time
   » Updated 16/05/2018
   » Mark Tierney this job is expired SaveSave Apply Now

Job detail


This Qualified Person will act as a key member of the Quality Assurance team connected with the production of our client's Biologics product.
 

JOB PURPOSE:

This Qualified Person will act as a key member of the Quality Assurance team connected with the production of our client's Biologics product. located at this top Pharmaceutical company's manufacturing campus in Dublin this QP will be reporting directly to the Head of Quality for this product.

The main responsibilities are:
The responsibilities of the Qualified Person will include the following:
   » Management of batch disposition and material status control activities connected with the drug product, acting as a site Qualified Person.
   » Communication and liaison with other departments on Quality issues, providing guidance and support to others.
   » Assisting in investigations on deviation management, root cause analysis and CAPAs.
   » Co-ordinate Change Control process connected with production.
   » QA oversight.
   » Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
   » Management of review of BMRs.
   » Implement of KPIs within the Quality Assurance Participation in the site Internal Audit programme.
   » Prep and host for external Audits from regulatory bodies including prep of documentation.
   » Promote quality culture.
   » Acting as a designee to the Head of Quality as required.

Requirements:
   » Meet the educational standards of a Qualified Person as per EU Directive 2001/83/EC.
   » 3rd Level science degree.
   » Sterile manufacturing practice essential.
   » Biologics manufacturing practice.
   » Minimum 5 years practice in a quality function.
   » Excellent expertise of GMP as described in current FDA & EMEA regulations for Biologics pharmaceutical manufacture.
   » Must be a self-starter with strong initiative.
   » great project management expertise.

To discuss this opportunity in greater detail Contact Us by Dominick O'Driscoll from Clarity Recruitment on +353 1 5673123 and by submitting a CV for an immediate confidential review.
Ref: QP-BIo/ste
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Clarity Recruitment


   »  


   » 93 Baggot Street, Dublin 2
   » 01 532 5441
   » enquiries@clarityrecruitment.ie
   » http://clarityrecruitment.ie



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Dublin
Company Type Employer
Post Date: 05/16/2018 / Viewed 13 times
Contact Information
Company: Clarity Recruitment
Contact Email: enquiries@clarityrecruitment.ie


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