Qualified Person

3 weeks ago

Ballina, Mayo County, Ireland Team Horizon Full time

Team Horizon is seeking a Qualified Person for our Clients state of the art sterile manufacturing facility. The role will provide support in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as laid down by the FDA, EU and regional Ministries of Health as relevant.Why you should apply: * This is an opportunity to join a leading biopharmaceutical manufacturing company who work across several therapeutic areas. * Working closely with a Director of QA you will you will have QA oversight of all activities in the business unit ensuring the necessary GMP requirements are met, and you will hold responsibility for certifying all batches manufactured in the business unit.What you will be doing: * The QP will approve all records generated by the business unit, including but not limited to batch records, exception reports, validation documents and product quality review reports. * Provide quality input for all activities undertaken within the business unit. * Represent the company in all business unit for Agency inspections, ensuring the unit is inspection ready. Ensure any non-conformances and open commitments related to the business unit are addressed. * Evaluate and disposition all batches manufactured in the unit. * Provide guidance on all non-conforming material/ batches. Direct the investigation and determine the release disposition of such material/product. * Participate in the business unit OPEX activities providing quality input * Direct the activities of the QA and Product release personnel within the business unit to ensure product is released and activities are undertaken in a compliant manner. * Motivate employees to ensure all activities are performed in a GMP compliant manner through effective communication. * Provide direction to all quality personnel based in the Business Unit, including QC, Product Release, Compliance and Bioassay * Provide guidance to all business unit functions to ensure activities are completed in a GMP compliant manner. * To agree with the Director of QA and Business Unit Leader the delivery of the company quality plan and global regulatory requirements providing appropriate, timely information as required. * Anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry. * Assess quality implications of new regulatory guidance and implement necessary changes to business unit processes. * Provide quality input for proposed process changes within the business unit * Manage quality requirements for New Product ImplementationWhat you need to apply: * Degree in a Pharmaceutical Science or Relevant Scientific Discipline * Recognized QP qualification * Minimum 5 years Proven track record in a quality discipline in the Pharma industry

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