Senior QA Associate
- Permanent
- Quality Assurance, Quality Systems
This vacancy has now expired. Please see similar roles below...
Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a Senior QA Associate to ensure QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.
Job Responsibilities:
- You will be accountable for the management of the organisations Quality Management System.
- Maintain QA KPI metrics.
- Generation, Review and approval of relevant GMP documentation.
- Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
- Complete internal audits and inspections and audit write up.
- Co-operate with Operational areas, proactively manage the day to day QA Operations.
- Review Batch documentation and manage QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
- Manage and support QA team Facility walk rounds and QA support for all operational areas.
- Deliver direct quality team support during customer and regulatory audits.
- Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA's and Change Controls.
- Provide QA review for the eQMS system.
- Create and review Risk reporting and Mitigation.
Key Skills:
- Strong verbal and written communication skills.
- Excellent interpersonal skills.
- Good organisational and time management skills and able to demonstrate flexibility and adaptability.
- Able to prioritise workload, decisive thinker able to work within agreed timescales.
Requirements:
- Prior experience working in a GxP environment including a minimum 5 years' experience in Compliance and Quality Assurance.
- IT literate, experience managing and operating an electronic QMS.
- Experience of working within a GMP manufacturing environment.
- Understanding controlled processes.
- Proficient in Microsoft Office and experience in database use and eQMS systems.
- Knowledge of GCP and GMP with regards to QMS activities
- Experience in Competent authority, Regulatory body inspections and audits.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Similar jobs
Negotiable
Basel, Schweiz
Hobson Prior is seeking a Quality Assurance Specialist for a contract role based in Basel.
€40000 - €45000 per annum
Galway, Republic of Ireland
Hobson Prior are looking for a QA Compliance Officer to join a fantastic pharmaceutical organisation on a permanent basis located in Galway.
€130000 - €160000 per annum
Herrenberg (71083), Deutschland
Hobson Prior are seeking for a Head of Quality to join a pharmaceutical organisation. This role is on a permanent basis and is located in Herrenberg.
Negotiable
Charleroi, België
Hobson Prior are currently looking for a GCP QA Director to join a brilliant pharmaceutical organisation on a contract basis located in Gosselies.
Can’t find what you’re looking for?
We don’t advertise all of our vacancies online. Register with us and we can let you know the next time your perfect role becomes available, or want to discuss your options with a specialist?
Register