Qualified Person - Biosimilars & Generics

Employer
Invenia Group
Location
UK
Salary
Competitive
Closing date
10 Aug 2021

View more

Sector
Engineering
Contract Type
Permanent

Job Details

Qualified Person - Biosimilars & Generics

Please note this role will not offer sponsorship.

Invenia is partnered with a leading supplier of generics and biosimilars with offices in over 25 European countries. This exceptionally fast paced and growing business is looking to hire a Qualified Person in order to support EU/UK GMDP requirements and ensure that an effective Pharmaceutical Quality system is maintained.

Role Duties:

  • To support the Site Quality Head in maintaining and continuously improving GMDP standards
  • Build in house know how, capacity and capability within the quality team to support business growth
  • To perform the Qualified Person duties in accordance with Directive" 2001/83/EC (amended by Directive 2004/27/EC) and following the guidance laid down in Annex 16 of Eudralex Volume 4 - Good Manufacturing Practice.
  • To carry out the routine duties of a Responsible Person in accordance with the EU GDP Guidelines 2013/C 343/01 and to ensure that all conditions of the Wholesaler Distribution Authorisation (WDA) are met.


Opportunity:

  • This role will give you experience of effervescent, non-effervescent and sterile products.
  • To provide process improvements to production and cross contamination
  • Implementing lean manufacturing principals
  • Exposure to a microbiology lab


Key Requirements:

  • Experience in working as a qualified person within manufacturing facilities, including batch certification
  • A detailed understanding of oral solid dose manufacture / packing and related product transfers
  • Experience of importing and certifying products from outside the EU
  • Experience of hosting MHRA GMDP Inspections


Professional Experience:

  • Degree in science discipline
  • Qualified Person certification in UK under the permanent provisions


If you are interested in proceeding with this opportunity, please send your up-to-date CV in English.

Please note this role will not offer sponsorship.

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