Our client is a fast growing global pharma multinational based in Dublin. We require an experienced Quality Control manager.
QC oversight and effective management of contract test laboratories utilized from release and on-going stability testing.
Development of strategic short-term and long-term approaches to release and stability method performance and improvements, analytical support for process improvements, product comparability assessments.
Interpretation of data trends for both release and stability, life cycle of methods and other technical support as required.
Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives.
Lead investigator with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
Participate in cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs.
The position may require approximately up to 20% travel.
Person Spec :
Experience of Technology Transfer of analytical methods.
Ph.D. in Chemistry, Biology or other related fields with >5 years of relevant Postdoctoral/Industrial experience or M.S. with >7 years of relevant experience.
Experience dealing with contract testing organisations is preferred
Team leadership. Good knowledge of statistical techniques in the use of problem solving data analysis.
Ability to demonstrate standards of leadership - managing complexity/ innovations.
Customer Focus Flexible Team Player Good influential skills.
Regulatory filings and inspections.
Strong knowledge of EU cGMPs and FDA guidelines.
Experience with lean processes
For further information on this Quality Control Senior Scientist and Technical Lead position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment
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