Ensure timely and proper sampling as per SOP.
Reduction in Testing time to avoid down time in and loses in production.
Ensure closure of complaint in defined timelines with implementation of CAPA.
Review the implementation of CAPA for any non-compliances to maintain the upkeep of the plant as per regulatory norms.
Ensure sustainability of QMS (Deviations, Change control, OOS and Incident reporting) with QRM
Ensure timely batch release
Ensure regulatory compliance, availability of valid Licences and certificates at the plant
Ensure availability of customer specific certifications for the plant
Handle customer audit independently at the plant and provide support for the team in facing the audit.
Provide support to the New Product development with QMS & QRM
Responding on Time to relevant stakeholders
Internal process
Water validation data for phase I and phase II
Daily analysis of water, sampling of water from different location
MLT for product testing, environment monitoring, calibration of various instrument
Sub culturing for different culture.
SOP & WI Preparation. Stability and Revalidation.
Planning and carrying out trials with tracking environmental microorganism development
Collecting samples from a variety of locations.
Recording, analysing, interpreting data and managing laboratories.
Keeping up to date with scientific and research developments.
Ensuring that data is recorded accurately in accordance to guidelines.
Review Quality data metrics jointly with the team and QC head
Ensure closure of internal and external customer audit points.
Provide support to internal functions
Support new vendor development process by RM/PM testing and evaluation.
Safety, Health & Environment (SHE)
Ensure a "Zero Incident" safety culture and lead root cause investigations for any incidents/near misses.
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