QA Operations Lead
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Hobson Prior are seeking for a QA Operations Lead to join a brilliant pharmaceutical organisation on a permanent basis. Our client is focused on offering emergency care and rare disease solutions for healthcare needs.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will guide and guarantee compliance of the deviation procedure, which involves categorisation and approval of deviations, guaranteeing compliance with cGMP, quality and regulatory standard needs.
- Assist any other functions in recognising corrective and preventive actions, root cause determination, complete failure investigations, and follow up to corrective and preventive actions, guaranteeing closure in an adequate and timely manner, as well as raising significant events as suitable, guiding the triage meetings for significant concerns.
- Produce and grow cooperative and trusting relationships with manufacturing team and form effective communication.
- Contribute to the development, upkeep and improvement of the deviation and risk management procedures to meet the needs of the pertinent regulatory authorities, informed bodies if applicable and any other suitable quality and regulatory standards.
- Responsible for the management and oversight of the batch evaluation and release process working cross functionally with any other site functions.
- You will track outstanding activities to meet targeted release dates, raising risks to senior management.
- Guarantee that KPIs are upheld and guide action plan improvements when required, assisting any other divisions in efficient decision-making processes.
- Any other assigned duties.
- Educated to a degree level in a scientific field such as chemistry, biology or medical technology would be ideal.
- Attained a recognised quality qualification, such as CQI Diploma in Quality or demonstration of satisfactory experience within QA department or demonstrated adequate experience in the similar role.
- Familiarity in a drug manufacturing within GMP setting or biologics organisation within a Quality Assurance, Quality Control or Quality Engineering role.
- Knowledge in document control systems.
- Prior involvement with both internal and external audit procedures.
- Expertise on cGMPs, Notified Body, MHRA, FDA guidelines and SOPs.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.
€40000 - €50000 per annum
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