Our client is a major multinational biopharmaceutical company with an exciting drug portfolio driving double digit growth, creating highly attractive new career development and advancement opportunities at their globally focused Dublin city HQ.
- The Quality Systems and Compliance team is responsible for for Quality Systems and Compliance for Biologics products in our client’s external sites and external contract manufacturing and testing organisation for Drug Substance, Drug Product and Finished Drug Product manufacturing.
- This team will work with our external CMO /CTL partners and internal Quality teams within this department. In addition this function works closely with Global Systems and Compliance, External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 6 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting audits and/or involvement in preparation for Health Authority inspections.
- Interpersonal skills and communication skills to interact with CMO /CTL partners and other functions.
- Must be able to prioritise in a busy environment.
- Must be able to travel -approx 20% (domestic and international)
- Must be fluent in English
For further information on this Quality Systems and Compliance Specialist position please contact Gavin Kennedy at The RFT Group on 01 2302400 / firstname.lastname@example.org. Check out all our open jobs on our Recruitment Website: www.rftgroup.ie
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