QA Document Control Specialist

Cork
Contract
Full-time

1 day ago
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About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Overview:The Quality Assurance Document Control (QADC) specialist is responsible for maintaining and continuous improvement of site quality systems, providing quality oversight of the facility with a focus on document management quality system.RequirementsResponsibilities:

Process site-controlled documents on the site Document Control System.

Approve document change controls and establish document effective dates.

Complete work according to established priorities and policies to assure product documentation is delivered on schedule.

Support and train other staff members on the implementation of global improvements related to the Document Control System.

Train and support other staff members on the use of the Document Control System.

Maintain the Sites Document Store and escalate any potential issues.

Control and issue controlled document numbers as required.

Support Inspection Readiness for the site and the site in preparation for upcoming inspections.

Examine the Quality Metrics related to the Document Control System.

Participate and support Continuous Improvement for the Quality Team.

Other duties may be assigned as requested.

Education/Experience:

Strong communication and organisational skills required.

Experience with QMS and EDMS systems is desirable.

Experience with excel / metrics generation is desirable.

PSC Biotech