QA Specialist - Biopharma - 7am-3.30pm
- Dublin
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Could be some quite nice working hours for some - 7am - 3.30pm. (Some support may be required outside of these working hours on occasion)
Duties to include
- To assist in the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements
- Identify opportunities and support continuous improvement of enterprise QMS processes and associated systems
- Monitor QMS process performance to identify trends and best practices
- Author, review and approve of QMS procedural documentation and work instruction
- Create and deliver Quality Systems training (process and technical)
- Compile and present QMS monthly & quarterly metrics at Quality Management Review
- System user access management
- Participate in inspection readiness activities and internal/external audits and inspections.
Skills:
- 5 years’ + QA experience within the pharmaceutical industry
- Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments
- In-depth knowledge of global cGxP requirements for quality systems
- Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions
- Excellent communication skills with all levels of the organization and Health Authority representative
- Knowledge of medical device quality system requirements desired
- Direct experience with TrackWise desired.
- Project Management and Lean Six Sigma certifications a plus.
- Qualified Person designation a plus.
- Bachelor’s degree in a technical or life sciences discipline
Call me for more information on this vacancy !
The candidate must have the rights to work in the location stated in the job advert.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Wendy
I manage this role.