Provide leadership and effective management of analytical services, expanding operational capabilities to cater to varied analytical testing requirements, plan and implement automation, provide operational support to business development and efficient use of manpower
Provide subject matter guidance and be responsible for cost effective Method development, validation and analysis using state of art analytical instruments (LC/MS, GC/MS, TOC,)in a QC and bio-analytical lab setting. Must be well versed with protocol and reporting requirements in accordance with GMP/GLP requirements.
Responsible for review and approval of analytical instrumentation including its documentation
Ensure compliance to international regulatory requirements and meet quality standards of the organization
Training and mentoring of Lab staff
- Direct staff and laboratory staff for analytical method development,validation and analysis for submission to international regulatory bodies.
- Design review and approval of validation plans, protocols, operating procedures, and study schedules for method validations and sample analysis.
- Continuously evaluate operating procedures and implement changes to bring in efficiencies
- Independent resolution and troubleshooting of analytical issues
- Ensure appropriate quality standards are maintained
- Ensure compliance to FDA 21 CFR Part 11 requirements
- Effective, investigation of failed batches, in method validation and production runs are documented and a root cause and impact analysis are carried out with CAPA implementation
- Ensure good documentation practices are followed
- Compliance to Globyz policies, quality systems and Safety commitments
- An advanced university degree / PhD in analytical chemistry or pharmaceutical sciences. Possess a thorough understanding of analytical technology, pharmaceutical chemistry, and comprehensive knowledge of ICH and US FDA regulatory requirements.
- Ten to fifteen years of relevant experience in a QC setting or a similar discipline pharmaceutical/bio-analytical setup
- Has been involved in setting up and running an analytical testing lab
- Experience and advanced knowledge of analytical chemistry and instrumentation involving liquid and gas chromatography
- Effective written and communication skills
- Experience in defending studies with regulatory bodies
- Requires good interpersonal skills, prior experience in leading a team in a laboratory setting
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