- QC oversight of our client’s contract test laboratories utilized for release testing and on-going stability testing
- Interpretation of data trends for both release and stability, life cycle of methods in alignment with the QC method development team and other technical support as required.
- Drive investigations with strong understanding of compliance and cGMP's, strong scientific judgment in decision making.
- The scope includes drug substance and drug product
- Works with our clients external CMO/CTL partners and internal Quality teams within this department. In addition this function works closely with External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.
DUTIES AND RESPONSIBILITIES:
- Building/sustaining collaborative relationships within Quality, and stakeholders across the organisation
- Regularly interacting with internal and external stakeholder groups to understand needs and collaboratively resolve issues in order to meet patient and business needs
- Timely testing and reporting of accurate data
- Supporting method transfer projects and lab audits/inspections
- Supporting the establishment and revision of product specifications
- Expeditiously and objectively investigating laboratory exceptions and supporting manufacturing investigations. Escalates where further input is required
- Timely trending of data and operational key performance indicators
- Identifying and/or remediating technical, compliance, and efficiency gaps
- Anticipating, monitoring and addressing evolving and new regulatory requirements
- Authoring/reviewing regulatory submissions
- Establishing/improving technology solutions to support people and processes
- Providing accurate and timely updates of group activities to Quality and Technical Operations management with a focus on compliance, cycle times, cost management, and productivity
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Ph.D. in Chemistry, Biology or other related fields, or BSc/MSc with >6 years of relevant experience.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting lab 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 QC Specialist position please contact Gavin Kennedy at The RFT Group on 01 2302400 / email@example.com. Check out all our open jobs on our Recruitment Website: www.rftgroup.ie
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