QC Chemist III- Equipment Qualification, Permanent role
- Analytical method transfers & validations process and cleaning validations for New Product Introduction
- Ad-hoc technical investigations; Commercial release as required
- Generation, review and approval of validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
- Method Validation Gap Assessments, Pre Transfer Training, Method Transfer/Validation, Transfer to Commercial
- Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
- Leads and coordinates reviews and investigations for out- of trends/out -of specifications.
- Troubleshoots instrumentation/test methods and associated corrective maintenance as required
- Represent QC and participate in cross functional teams. Provision of analytical testing status updates at governance forums.
- Escalation of risks and implements appropriate mitigations
- Timely completion of Change Controls, CAPAs, Tasks etc
- Assists in the training of QC staff as needed.
- Conducts GMP reviews of logbooks
- Implements LEAN and 5S initiatives as required.
- Data review to ensure compliance to appropriate specifications and protocols.
- BS degree in Chemistry or equivalent
- 4-5 years of relevant experience
- Proficient in HPLC, LIMS & Empower - a distinct advantage
- Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & Troubleshooting and problem-solving skills to support root cause analysis
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
- Strong verbal, technical writing and interpersonal communication skills are required.
Proficiency in Microsoft Office
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