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Qualified Person - Dublin North

Recruitment Plus

  • Louth / Meath / Dublin North
  • Negotiable
  • Permanent full-time
  • Updated 06/12/2017
  • Zuzana Foley
this job is expired
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Description

Qualified Person - Dublin North - D004882 Please hit the apply now button above and Zuzana who is based in our Dundalk office will be in contact if you are suitable.

 

Qualified Person - Dublin North - D004882

Recruitment Plus is currently recruiting for a QP who will perform key quality responsibilities with respect to certification of batches of medical products prior to release for sale or distribution, including Medicinally Licensed over the Counter products as well as third party manufactured medicinal products.

The role also provides release support for cosmetics and Medical Devices as relevant.

Candidates must stay current with proposed and implemented regulations and understanding industry trends.

Interface and collaborate with corporate and functional area management as well as CMO management teams to ensure systems utilised for quality oversight and management are compliant and consistent with corporate standards

 

Requirements:

Qualification requirements as laid down in the Directive 2001/83/EC (the Pharmaceutical Directive) (Human Medicines) and also the requirements as defined in the following directives:

  • EU Directive 2003/94/EC (GMP for medicinal products for human use)
  • The Rules Governing medicinal Products in the European Community, Volume 4: Medicinal products for human and veterinary use: Good manufacturing practices.

 

Detailed Responsibilities:

  • Act as Qualified Person for release of products in accordance with article 51, EC directive 2001/83/EC
  • Act as QP representative for regulatory inspections where necessary. Where appropriate communicate directly with Regulatory Agencies
  • Ensure all relevant manufacturing licenses are maintained
  • Participate in Continuous Professional Development (CPD) initiatives with a view to maintaining, developing and broadening knowledge and skills as they relate to the function of Qualified Person. (Including presentations, tutoring, workshops, self-learning reading, formal academic education etc.)
  • Maintain a knowledge of the Role and Responsibilities of the Qualified Person at all times. For example, familiarization with literature such as ECA Good Practice Guide for Qualified Persons within the EU
  • Ensure that all core competencies are of a level to provide full cover of all QP related activities
  • Review deviation reports including all associated CAPA’s and investigations ensuring that any deviations or planned changes with a potential to impact the product have been authorized
  • Participation of deviation investigation where deemed appropriate
  • Ensure any changes requiring variation to the manufacturing authorisations (MIA) have been notified and authorized by the relevant authority
  • Ensure each batch certified and its manufacture complies with the provisions of the marketing authorisation. Ensure all necessary checks and tests are adequate and performed correctly
  • Maintain a register (or equivalent document) as a record of product batches certified by the Qualified Person prior to release
  • Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate
  • Review, approve and assist in the compilation of Product Quality Reviews as appropriate.
  • Participate in regulatory, corporate and customer audits of sites when required
  • Review product customer complaints where appropriate
  • Review and approve GMP associated documentation/protocols as appropriate
  • Liaise with other functional groups to maintain and improve Quality Systems
  • Compile and communicate KPI’s / metrics associated with QP activities as necessary
  • Provide QP oversight to contract manufacturing facilities contracted by company to ensure on-going compliance to marketed product
  • To provide a reliable, responsive and professional QP service to operations
  • Any other tasks/objectives requested as appropriate
  • May participate in department initiatives and projects
  • Overseeing quality system for medical devices as defined as per Medical Device Directive 93/42/EEC and ISO 13485

 

Please hit the apply now button above and Zuzana who is based in our Dundalk office will be in contact if you are suitable.

Unfortunately, Recruitment Plus is not in a position to respond to each individual application due to the high volume of submissions. We will only contact those candidates whose CV matches the criteria for the vacancy. Thank you for your patience.

At RecruitmentPlus, we respect your privacy. Your CV is sent to us in complete confidence and will never be forwarded to a third party without your consent.

Ref: D004882
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