Analytical Specialist-Emerging Markets
Job Description
New Submissions/Launches:
Work closely with IPDO team on identification of equipment required for procurement at Brazil QC and support in the installation/Qualification activities for new submissions.
Review and support on Query responses for new submissions (related to QC queries).
Work closely with Launch team and QC team on Launch related activities- ensuring the Standards or other pre-requisites well in advance to receipt of commercial batches
Method transfer support: Work closely with Project team on plan of Method transfers to DRB & Partners.
Batch releases: Support to QC team in planning and troubleshooting based on the need. Support in Investigation of Incidents, OOT, OOS. Tracking of CAPA and ensuring closure as per stipulated timelines.
Lab compliance/Audit support: Review of Documentation practices as per GMP. Review of SOP for compliance and revision in line with Global SOP Streamlining of practices at Brazil QC in line with Global SOP procedures
Support in Inspection by regulatory agencies/internal teams ensuring anytime audit readiness. Support on closure of Inspection observations and remediation plan.
Quality Review meeting with DRB QC and QA To execute weekly review meetings for tracking of occurrences, OOS, OOT, change controls, market complaints and Batch release status. To execute monthly review meeting with management
Requirements
Function: Quality Assurance
Experience Level: Executive