Job Description
Our client, a leading Biopharma company based in Dublin, now require a Senior Qualified Person to join their expanding team who will provide leadership and development to the QP team and QA staff. Additionally, this hire will act as Associate Director of Quality Assurance when required.
This is a hybrid role, requiring onsite presence the majority of the working week. This is a permanent role; with generous salary with benefits package.
The Senior Qualified Person is responsible for leading the Quality Assurance team and promoting their development, with responsibility for production of oral solid dosage product and the release of the product (specifically API/DP operations) in accordance with EU Directive 2001/83/EC.
The successful candidate will be responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the site.
Responsibilities for Senior QP:
QA Oversight of (specifically of API/DP operations) in the production facility.
Management of batch disposition and material status control activities associated with, acting as a site Qualified Person.
Management of review of Batch Manufacturing Records (BMRs).
Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
Implementation of KPIs within the Quality Assurance area to align with company and global quality objectives.
Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
Motivation, training, discipline and appraisal of Quality Assurance staff.
Requirements for Senior QP:
Bachelors Degree in a Science or related discipline.
Qualified Person status, as per EU Directive 2001/83/EC.
2-3 years’ experience working as a Qualified Person, with minimum of 5 years’ QA experience in the pharma industry.
Experience of oral solid dosage manufacture.
Excellent knowledge of GMP as described in current FDA & EMEA regulations for oral solid dosage pharma manufacture.
Excellent verbal and written communication skills.
Strong project management and organisational skills.
Ability to adapt to changing priorities.
People management experience is desirable but not essential.
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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