Quality Control Senior Scientist and Technical Lead Dublin pharma
Our client is a fast growing global pharma multinational based in Dublin. We require an experienced Quality Control manager for an immediate start maternity cover.
- 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.
- Creates and presents trending and metrics reports on deviations and corrective actions.
- Lead management of the document change requests for method SOPs.
- Provide representation to tech transfer and CMC teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers.
- Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies.
- 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 organizations 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
Cv to Gerry@rftgroup.ie 01 2302400