Senior Quality Engineer
Our client is a Global Pharmaceutical Manufacturer that focuses on Human Vaccine Discovery, Development, and Manufacturing and they are looking to hire an experienced Senior Quality Assurance Engineer to join their expanding team.
This is a permanent role based onsite in Co. Louth. The successful candidate with work within the QA department, and act as a QA representative in support of qualification activities for facilities, utilities, equipment, computerised systems, cleaning, process, storage areas, controlled temperature units (CTUs) and shipping.
They will be responsible for providing the company with technical and quality resources to schedule and manage quality validation deliverables on projects relating to, coordinate the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective quality system.
- Provide daily technical support to a team of QA Engineers and Computerised System Quality Specialists (CSQSs).
- Support team schedule management to ensure project needs are met.
- Quality review and approval of qualification/validation documentation and associated data for; facilities, utilities, equipment, computerised systems, cleaning, process, storage areas, controlled temperature units (CTUs) and shipping data, to ensure compliance with cGMP, industry standards and regulatory requirements.
- Quality review and approval of Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
- Preparation of SOPs relating to QA Validation Activities.
- Work in conjunction with all relevant functions to co-develop design verification & validation protocols for equipment, facilities, utilities, systems and processes, review and approve protocols/studies, and perform general oversight responsibilities for all validation processes.
- Review and approval of events/deviations, investigations, CAPAs and change evaluations that occur during qualification/validation activities, ensuring adherence to SOPs and cGMP requirements.
- Perform QAV and CSQ release of equipment for GMP purposes.
- Perform all activities in compliance with safety standards and associated SOPs.
- A third level degree in a scientific/technical discipline (e.g. biochemistry, chemistry, engineering,).
- Min 3yrs experience in Quality Engineering / Quality Validation role for Biologics, medical device or pharmaceutical manufacturing in a FDA/ EU regulated environment.
- Experience in deviation, change control, non-conformance, corrective and preventative actions.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
- Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
*Full Job Spec available on Request*
For a confidential discussion about this opportunity please contact Ranait Coughlan
(090) 6450664 (01) 66 200 88