Kate Edwards is recruiting for a Senior QC Specialist to join a global biopharmaceutical company at their site based in Dun Laoghaire near Dublin on a contract basis for 12 months.
The main purpose of the role will be to:
Function as the specialist for non- core project team (NPI) under minimal direction and be responsible for one or more of the following activities in QC including analytical testing, characterisation, sample, data management, equipment qualification and Project management.
Act as site representative for laboratory upgrade projects.
Plan and manage QC related activities from site projects.
QC Representative for NPI activities and routine Product meetings.
Manage all sample management activities related to NPI activities throughout the site.
Sample shipments and temperature monitoring activities for NPI activities.
Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
Be responsible for own training and safety compliance.
Assist with resource management, QC Project Management and other work streams as required by the lab management.
Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.
This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
Bachelor's degree in a Science related field is required.
Strong biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry is essential.
Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls).
You will have experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Broad technical knowledge within QC.
You will have good presentation skills with strong teamwork and Coaching, negotiation and influencing skills.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference DH40769 in all correspondence