QA Specialist required to work for a global biopharmaceutical organisation in Dublin providing oversight for Quality Activities within the QC Department.
Ireland is a hive of activity for the Life Sciences Industry at present with global players investing heavily here. An excellent site-based position has arisen with a large Biotech manufacturing facility in Dublin. You will be required on site 40 hours per week Monday - Friday.
The QA Specialist for Quality Control will be responsible, with management support, for providing oversight of quality activities associated with Quality Control
You will be responsible for quality oversight of the Quality Control Department. This responsibility includes the oversight of the QMS related to QC to ensure that quality and compliance requirements are followed in line with business needs.
- Responsible for Quality oversight, with management support of quality control.
- Provide Quality support to QC department to include method transfer or validation/verification activities.
- LIR review and approval.
- Provide oversight to continuous quality system improvements and support implementation of improvements at College Park in compliance, Calibration, Preventive Maintenance, Deviation Management and the Change Control Programs.
- Perform review of change controls deviations and CAPA’s.
- Provide QA and compliance support to projects impacting on Quality Control activities.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Responsible for quality review and approval of Cert of Analysis in accordance with internal procedures and GMP principles.
- Review and approval of standard operating procedures and controlled documents.
- Define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to Quality Control Operations. Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
- Assure ongoing compliance with quality and industry regulatory requirements
- Draft quality assurance policies and procedure
- Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Experience in QA for QC
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
- Demonstrated success records in auditing and improvement processes.
- Ability to operate efficiently in a complex matrix organisation and international environment.
- Management skills for management of a team of experts.
- Strong mature leadership and interpersonal influencing skills.
- Ability to represent the company and to negotiate at different levels contacts both internally and externally.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- Efficient in SAP, firstdoc. and Track wise.
For more information on this position, please apply with your up to date CV today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
QC Compliance Specialist - 12-month contract - Ireland QC Compliance Optimisation Specialist opportunity to work with a Global Bio-Pharmaceutical Organisation at their Manufacturing facility in
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