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Hobson Prior are working with a top pharmaceutical organisation who are looking for a QA Officer/QP to join them on a permanent basis Ireland.
- Accountable to help with due diligence and integration during new product developments / new product introductions.
- Support technical product transfers, qualification and validation work.
- Agree Quality Agreements with external partners (contract manufacturers, logistic service providers, clients and distributors).
- Responsible to investigate quality incidents, OOS, deviations and complaints, identify and follow-up CAPA's and supplier improvement plans together with contract manufacturers.
- Evaluate and follow-up Change Controls as per company procedure.
- Write Product Quality Reviews.
- Agree annual stability programs and review stability results.
- Be part of Supplier Qualification and Regular Supplier Auditing.
- Recognise gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
- Keep a going awareness of new and developing regulations related to GDPs and GMPs.
- Ensure ongoing inspection readiness.
- The Quality Assurance Officer Generics will act according to the companies' mission, vision and strategy.
- Strong project management skills and the capacity to work effectively in a multicultural environment.
- You are an enthusiastic team worker who gets the job done.
- Self-starter and capable of working autonomously.
- You will be travelling internationally on a regular basis (once a month).
- You speak and write fluently English; any other language is an asset
- Must have proven skills in Quality Assurance and Manufacturing.
- At least 2 years relevant experience in QA in the pharmaceutical industry with good knowledge of the relevant European regulations for manufacturing of pharmaceutical products.
- Master degree in pharmaceutical sciences, industrial pharmacy, engineering, biochemistry, chemistry or equivalent through experience and have at least 2 years of relevant experience in QA in the pharmaceutical industry.
- Qualified Person certification is desirable.
- You have good knowledge of the relevant European regulations for manufacturing of pharmaceutical products as well as good knowledge of the manufacturing process for injectables and tablets. Knowledge of and experience in FDA regulations is an asset.
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.