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Senior QA Officer, D24
Confidential
- Dublin, Dublin, Ireland
- Dublin, Dublin, Ireland
Über
If the following job requirements and experience match your skills, please ensure you apply promptly.
Dublin (Onsite) Our client is seeking an experienced and highly motivated Senior QA Officer to join their growing Quality team in our GMP manufacturing facility in Tallaght, Co.
Dublin.
The successful candidate will play a key role in maintaining and enhancing the Pharmaceutical Quality System (PQS), supporting GMP operations, and ensuring ongoing regulatory compliance across the site.
Key Responsibilities Provide quality assurance subject matter expertise across site operations.
Promote a strong quality culture and increase awareness of quality requirements throughout the organisation.
Support and maintain GMP document control processes, including document issuance, review, batch record management, and training systems.
Participate in periodic reviews of the Pharmaceutical Quality System (PQS) and contribute to its continuous improvement.
Support and execute internal audits and self-inspection programmes, ensuring effective follow-up of corrective and preventive actions (CAPAs).
Monitor and coordinate quality records including deviations, change controls, CAPAs, and audit-related activities within electronic quality systems.
Provide compliance guidance and support, ensuring quality issues are appropriately escalated and addressed.
Administer Quality Management System activities including document numbering, event tracking, and maintenance of associated logs.
Act as QA Archivist, ensuring the secure retention, storage, and retrieval of GMP quality documentation.
Ensure compliance with Good Documentation Practices (GDP), signature log management, and company records control requirements.
Coordinate document review schedules and follow up with document owners to ensure timely completion.
Manage the issuance, revision, obsolescence, and archiving of quality documents.
Create, review, and approve quality documentation and procedures.
Deliver training, auditing, and compliance support to departments across manufacturing and warehouse operations..
Essential Qualifications & Experience BSc degree (or equivalent) in a Scientific Discipline.
510 years' Quality Assurance experience within a GMP-regulated environment.
Strong understanding of GMP and GDP requirements.
Experience working with Quality Management Systems and electronic quality systems.
Excellent organisational and communication skills.
Ability to manage competing priorities and work effectively in a fast-paced environment.
Proven ability to apply risk-based decision-making and pragmatic problem-solving approaches.
Previous Quality Control experience.
Experience supporting audits and regulatory inspections.
Experience within pharmaceutical, healthcare, biotechnology, or related regulated manufacturing environments.
Why Join? Opportunity to play a key role in maintaining and enhancing GMP compliance.
Work within a collaborative and supportive quality-focused environment.
Contribute to the continued growth and success of a leading regulated manufacturing operation. xyswxtq
Be part of a company committed to quality, innovation, and continuous improvement.
If you are an experienced Quality Assurance professional looking to take the next step in your career, we would love to hear from you.
Benefits: pension healthcare holidays
TPBN1_IJ
Sprachkenntnisse
- English
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