Qualified Person
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002659 |
| Job Views | 973 |
- Description
- We have an exciting opportunity available for Qualified Person with our client who are a leading biopharmaceutical company. In this role, you will own, review, and approve SOPs and other GDP/GMP documentation and records, ensuring Corporate, Site and Regulatory requirements are met. You will also lead audits, provide guidance to departments regarding compliance with quality policies, standards, and procedures.
Why you should apply:
Join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions such as flex hours and WFH
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
Perform review and approval of validation documentation.
Lead and participate in internal and external audits as needed.
Maintain a close contact and familiarity with the client’s Quality systems and programs utilized at other client sites.
Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff regarding compliance with quality policies, standards, and procedures.
Evaluates and assess change control records, nonconformances and CAPAs.
Participate in global Quality initiatives as a site subject matter expert.
Participate or lead projects and improvement efforts including product launches.
Supports the evaluation of quality and distribution complaints.
Supports regulatory inspections or various questions from regulatory bodies.
Perform activities as required per client procedures as QA staff, and in particular where the role of QP is specified in the procedures.
What you need to apply:
University Degree in Pharmacy
OP University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC
Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation. Knowledge of applicable regulatory requirements
Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 2 years
