Quality & Laboratory

QC Chemist III- Equipment Qualification, Permanent role

RESPONSIBILITIES

• 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.
  

REQUIREMENTS

• 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
  Organizational skills.
• 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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