An excellent opportunity for a Senior Qualified Person ( QP) to join a leading biotech company based in Cork. For more than 25 years this company has been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The QP is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice in the Cork facility that is now operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
As QP you will be:
o Responsible for certifying DSP batches prior to release to filling site.
o Ensure that the batch and it’s manufacture comply with GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements.
o Maintain oversight of deviations and change controls and ensures that any issues which have a regulatory impact are notified to health authorities and mitigated as required.
o Ensures that all necessary tests and checks have been performed prior to batch release.
o Ensures that all necessary production and quality control documentation has been completed and endorsed by authorized staff.
o Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required.
o Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMO’s / contract test labs.
As QP you will have::
o MSc or Higher Diploma in Pharmaceutical Sciences/ Pharmaceutical Manufacturing Technology which fulfills the QP educational requirements.
o Industry experience within a QP role within a regulated biologics or pharma industry.
o Knowledgeable of FDA/EMA regulatory requirements.
o Strong problem solving skills and Design of experiments.
o Knowledgeable of FDA/EMEA regulatory requirements.
o Excellent interpersonal and communication skills.
o Self-driven and keeps up to date with regulatory, technical developments within the industry.
For full details on this role and the associated package please contact Kathy on 021 4777329 or apply directly through this advert.