Qualified Person
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3082 |
| Job Views | 1597 |
- Description
- Team Horizon has 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. You will ensure batches are manufactured & distributed as per Directive 2001/83/EC, Article 51.
Why you should apply:
This is an excellent opportunity to join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions
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:
Ensure that each batch of medicinal product has been manufactured and checked in compliance with the laws in force in that member state and in accordance with the requirements of the marketing authorisation.
Certify in a register or equivalent document, that each production batch has been manufactured and checked in compliance with laws in force in Ireland, is in accordance with the requirements of the marketing authorization and with EU Good Manufacturing Practice (GMP).
Perform activities as required per company procedures as QA staff, and in particular where the role of QP is specified in the procedures
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 Quality systems and programs utilized at other sites.
Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to 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.
What you need to apply:
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 OR University Degree in Pharmacy
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 5 years OR minimum of 2 years experience as a practising QP.
