This is an opportunity to be part of a dynamic team within the QA function. We are looking for individuals who will support and drive Chanelle Pharma's vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. This is a key role in the
Quality Assurance area reporting to the Senior QA Manager.
KEY RESPONSIBILITIES: Responsible for Quality Complaints ProgrammeEnsure timely acknowledgement of Customer Complaints and Appropriate logging within the QMSEnsure reports are written and approved within the required timeframeForwarding any associated Product Quality Defects to the respective Pharmacovigilance departmentLiaising with the HPRA for product quality defects reportingReview / lead Process investigations / Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.Support with Review and approval of Compliance documents e.g. Deviations, SCARS and CAPAs.Conduct Routine Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.Conduct annual GMP training to respective GMP Areas as and when scheduled.Quality review and approval of MWO's & PWO's.Provision/Updating of existing Quality ProceduresContributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.Preparing product quality review reportsTo carry out GMP walks as required.Support during Quarantine and Recall activitiesSupport or where necessary lead Quality based projects including working as part of a multidisciplinary team as required.Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.Support and participation in the monthly Quality Management & Review.Any other duties assigned by Quality ManagementCOMPETENCIES: Takes direction and asks questionsRelates well to the rest of the teamDevelops own technical skillsTakes a methodical, systematic and structured approach to organising workAbility to prioritise decision making differentiating between urgent and non-urgentEscalates issues appropriatelyOffers to help others when needed and creates a sense of harmony in the teamDisplays flexibility and shows willingness to learn and do that little bit extraQUALIFICATIONS: Minimum Bachelor's degree in a science-based disciplineMinimum of 2-4 years' experience in a pharmaceutical manufacturing environment with working knowledge of EU GMP and US FDA GuidelinesExcellent written and verbal communication skills through English
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training) Chanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.
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