Qualified Person
Brightwater
Tipperary
Are you an experienced QP looking for a challenging role at a new Pharma site in Munster or a newly minted QP looking to get experience working on a licence? Either way my client would like to speak with you! Principal Accountabilities. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Provision of advice on all aspects of Regulatory GMP Practices and systems. Design, develop and deliver training courses for QA/QP function on aspects on aseptic processes for finished pharmaceuticals. Actively participate in Plant/Quality committees and works with other site functional groups, such as the Production and Maintenance to help set direction for GMP initiatives. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Support the introduction of new products onto site in relation to Quality oversight, covering the end to end product release strategy. Responsible for certifying DSP batches prior to release to filling site. Ensure that the batch and its manufacture comply with GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements. 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. Ensures that all necessary tests and checks have been performed prior to batch release. Ensures that all necessary production and quality control documentation has been completed by authorized staff. Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required. Maintains knowledge and understanding of quality oversight for services and operations. Qualifications. Qualified Person Qualification as defined in EU GMP volume 4 and annex 16. MSC in Pharmaceutical Sciences/Pharmaceutical Manufacturing Technology/Industrial Pharmacy which fulfils the QP educational requirements. Industry experience with a QP role within a regulated biologics or pharma industry. Knowledgeable of FDA/EMA regulatory requirements. Excellent interpersonal and communication skills. Self-driven and keeps up to date with regulatory, technical developments within the industry. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2442 days ago