QA Specialist
- NI & Ireland
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
An exciting new opportunity for a QA Specialist to join a world Leading bio tech organisation who are at a peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
DUE TO TRAVEL RESTRICTIONS CAUSED BY THE CORONAVIRUS WE CAN ONLY ACCEPT APPLICATIONS FROM THOSE RESIDING IN IRELAND AT THIS TIME
Principal Responsibilities
- Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the BDS facility
- Review and approval technical support documentation. (Examples include cleaning, process, method validation).
- Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
- Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Responsible for review and approval of Master Batch Records in accordance with GMP principles.
- Responsible for review and approval of Master electronic Batch Record recipes in accordance with and GMP principles
- Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
- Provide quality oversight of calibration and preventative maintenance critically assessments as required.
- Author, review and approve Quality Related Procedures as required
- Support the Vendor Management Program.
- Support the Raw Material Qualification Program.
- Develop and report quality metrics
- Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Demonstrated success records in auditing and improvement processes
- Ability to operate efficiently in a complex matrix organization and international environment
- Strong mature leadership and interpersonal influencing skills
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- English fluency written and spoken (the Company language)
- Efficient in SAP, EMDS, MES and Trackwise.
Education
- Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
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
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
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
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