Qualified Person

HERO

Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Emma Griffin
email quality@hero.ie

Qualified Person

Apply Now

Job ID: JOB-12101
Qualified Person -12 Month FTC

I am currently looking to recruit a Qualified Person (QP) for a 12 month FTC. My client who is a pharmaceutical company is looking for this person to join their site in Sligo.

In this role, you will be responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.

Responsibilities:

  • Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
  • Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
  • Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
  • Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
  • Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
  • Ensure all audits have been carried out as required by the quality assurance system.
  • Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch.
  • Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Ensure that they have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification.

Qualifications and Experience:

  • Third level qualification in a science discipline with 5 years experience in the healthcare/pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
  • 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
  • High level of expertise is required to assess day to day quality issues.

For further information on this role in Sligo please contact Emma Griffin on 086 0334325/quality@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Emma Griffin

JOB-12101

Apply Now

Qualified Person

Emma Griffin

Role Type Fixed Term Contract
Contact Emma Griffin
email quality@hero.ie
mobile +353 86 033 43 25
linkedIn profile click here

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