- BBBH784870 Jun 14, 2021 Competitive
Are you a Commercial Quality Specialist in a regulated industry looking for new challenges ? An ideal opportunity to join Dublin based company for 6 months contract.
Immediate start - Competitive hourly rate - QA Specialist - Dublin based
Great opportunity to join an impressive portfolio UK and US Biotech Company in Dublin as a Quality Assurance Specialist. This role is an hourly rate contract and will offer a competitive rate for the right candidate. The successful candidate will have a minimum of 5 years experience in a similar role with responsibility for ensuring GDP standards are adhered too.
The core purpose of this role is to work closely with colleagues to develop systems and processes in line with related regulatory requirements, GDP and internal quality processes to ensure all documentation is complete for fit for purpose to support applications and inspections.
- Ensure that Policies and SOPs are executed in accordance with US, EMA, UK, and other global and local GDP criteria.
- To ensure timely product delivery to distributors, support the batch release schedule and procedure by liaising with operational departments, RP, QP, and supply chain organizations.
- Monitor GDP compliance with rules and corporate processes, as well as report issues, CAPA , and action plans.
- Update company on new legislation and regulatory changes
- Maintain accurate records of GDP operations completed at the WDA license holder site and assist in the review and implementation of Quality Improvement plans identified through regulatory inspections and audits.
- Over 5 Years experience in Quality Assurance / GDP related role
- Over 3 years in the pharmaceutical/biotech industry.
- Level 8 Science or Engineering degree
- Extensive knowledge of GDP and GMP regulations. Understanding of quality management systems and "good practices" (GxP), to ensure compliance with regulatory requirements.
- Ability to work independently and remotely with minimal direct supervision, as well as critical thinking skills.
For more information on this role or a confidential discussion please reach out today to Ula Niwinska - Specialist Global Quality & Validation Recruiter @ MMK Life Science Contracting - 021 2300 300 / email@example.com
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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