Job Description
Our client, a cutting edge-global Biopharma company now seek a Qualified Person (QP) on a contract basis to work on their Biologics Manufacturing facility in the greater Dublin area. This is a hourly rate role, rolling contract.
The Qualified Person will be responsible for certification of batches of finished product to be released to the EU/EEA, US and ROW markets which have been manufactured and checked in accordance with its marketing authorisation, the principles and guidelines of GMP and other relevant legal requirements.
Responsibilities for contracting QP:
Batch certification of finished Drug Product and management of a team to support such certification.
Management of the Batch Certification team to support release activities
Approval of change controls, deviations, trend reports and annual product quality reviews, as required
Oversight of compliance and quality activities including QRM, internal and supplier auditing, inspection management, records management, change control, and validation quality system approval
Collaboration with Quality, Regulatory and Supply Chain to support new product introductions
Review of quality agreements in support of the Batch Certification process
Actively support the Product Recall/Withdrawal processes for commercial products
Requirements for contracting QP:
Bachelors Degree in science, engineering or related discipline.
Eligible to act as Qualified Person on the Manufacturing/Importation Authorisation, preferably with previous experience acting as a Qualified Person for Finished Drug Product release
8 years’ experience in a role within the biopharmaceutical/pharmaceutical industry, 3 years of which acting as QP for sterile biologics.
Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations
In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
Direct experience interacting with Health Authorities and managing Health Authority inspections
Direct experience in interacting with external manufacturers
Ability to build relationships, partnerships and influence
Strong negotiation, communication and presentation skills across all levels both internal and external to company.
For further details, please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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