Quality Control Senior Scientist and Technical Lead

Job Title: Quality Control Senior Scientist and Technical Lead
Contract Type: Contract
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: about 6 years ago

Job Description

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.

Job Spec

  • 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