Qualified Person
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2859 |
| Job Views | 1634 |
- Description
- Team Horizon is seeking a Qualified Person for our Clients diverse manufacturing facility in Dublin.
Why you should apply:
Join a global, research-based biopharmaceutical company that combines leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
Be part of an organisation whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
What you will be doing:
Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
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 eduction 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
Ensure that each batch of medicinal product is certified in accordance with Volume 4, Guidelines for Good Manufacturing Practice including Annex 13 and Annex 16.
Review deviation reports including all associated CAPA’s and investigations ensuring that any deviations or planned changes with a potential to impact the products have been authorized.
Ensure any changes requiring variation to the manufacturing authorisations (MIA and IMP licences) have been notified and authorized by the relevant authority.
Ensure each batch certified and its manufacture complies with the provisions of the marketing authorization including the authorization required for importation of IMP’s where relevant). 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 QP prior to release.
Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate.
Review 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 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.
Support and adhere to established processes and productivity targets.
Provide status updates on own activities and productivity challenges according to defined procedures.
Support and adhere to established processes and productivity targets.
Any other tasks/objects requested as appropriate
What you need to apply:
Must satisfy the requirements as defined in the Directive 2001/83/EC of the European Parliament and of the counsel of 06 November 2001 on the community code relating to Medicinal Products for Human use.
Minimum 5 experience working in drug product manufacturing and packaging, including analytical chemistry, quality assurance and quality control.
Strong knowledge of EU and FDA cGMPs
Experienced in interfacing with regulatory agencies, Regulatory Filings and working with Regulatory Affairs
Laboratory experience including method validation
Thorough understanding of quality systems.
Auditing experience.
