Our client is a world class Biopharma Company whose mission it is to develop and commercialise innovative biopharmaceuticals for rare diseases.
They are seeking an experienced QP (Qualified Person) to join their growing teams in Cork on a permanent basis, remote working available.
Excellent Salary & Benefits package on offer
The QP is responsible for fulfilling QP responsibilities in relation to batch release of commercial (product for sale or supply in the EU or for export) and clinical product, in accordance with the requirements of EC/2001/83, EC2001/20 and Annex 16 and 13 requirements
This includes release of Products that are manufactured at the Cork site and/ or Contract Manufacturing Organisations.
The QP is responsible for ensuring that, prior to the certification of any given batch of formulated bulk drug substance, drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
- The QP is responsible for the Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards
- The QP will take part in Material Review Boards, CMO Quality Reviews, Supply planning and Product Governance Meetings.
- The QP will be involved in product complaint investigations, quality defect investigations and for deciding the measures to be taken to manage any potential risks presented by these issues including recalls.
- The QP will partner with other departments and with CMOs providing Quality Oversight of CMOs.
- The QP will support major investigations and deviations
- The QP will review and approve Product Quality Reviews
- Relevant Degree qualification or higher
- QP Qualification and status with min 3-5 years of relevant experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA)/ IMP (MA) within the Pharma or Biopharma Industry. Aseptic / Sterile Drug Product manufacturing experience essential
- Min 8 years of experience, in an EU licensed facility in a relevant functional area.
- Experience with IMP's (Investigational Medicinal Products) desirable
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
WHATS IN FOR YOU?
- Excellent salary and benefits package
- An opportunity to work in a cutting edge environment with a company that makes a really meaningful impact on patients' lives
- A chance to work in a new high tech manufacturing facility with excellent career development opportunities
- Flexibility and healthy work/life/balance: Remote working available with this role if preferred or can also be site based.
Click ''Apply Now'' or send me an email if you are interested in finding out more about this amazing opportunity!
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