To ensure effective implementation of cGMP, GLP, organization policies, safety, Health & Hygiene policies,
To be the part of / designate some equivalent person for audit and qualification of vendor for incoming materials (raw materials & packing materials)
in coordination with purchase and QA department.
Planning and monitoring for timely sampling and analysis of Incoming materials, which includes raw materials, packing materials and product contact materials .
Planning and monitoring for timely sampling and analysis of In-process and finished products samples, which also includes validation samples.
To ensure that all the relevant documents are completed and maintained online.
Planning and monitoring for timely completion of all calibration activities for instrument, equipment and any other supporting systems.
To ensure that none of these are used without appropriate calibration and all such instruments / equipments are maintained and available in calibrated state, ready for use.
Planning and monitoring of timely installation and appropriate qualification of all new instruments/equipments in co-ordination with vendor/QA/outside agency where applicable.
Review of Quality Control - Analytical Portion of TTD of various new products submitted by R&D.
To plan for preparation of various specifications, Method of Analysis (Standard Test Procedures), Work Sheets, etc., and to finally approve the same for implementation.
To ensure the timely (well in advance before the actual exhibit batch production) qualification/validation / transfer of analytical methods for new products in co-ordination with R&D, QA.
To ensure that all such relevant documents/records are reviewed maintained online.
To plan and monitor for the timely completion of the relevant documents/data/records for ANDA submission.
To co-ordinate with QA/RAD/R&D for any correction or revision in such documents as per the recommendations.
In co-ordination with QA, to ensure that Quality Management System is effectively followed in the department,
with respect to timely intimation and filing of various incidences, change control, deviations and investigating the root cause and effective implementation of CAPA to avoid future non occurrences.
To notify immediately to Head QA/QC for any OOS and to investigate the same in co-ordination with QA and production as per SOP.
To submit the investigation report to Head QA/QC for further actions.
To ensure that departmental activities are maintained on regular basis as per the requirement of various regulatory and customer audits.
To address the audit observations timely, for compliance with proper investigation and or change control/CAPA, etc.,
To ensure the appropriate inventories are maintained in the department for all chemicals, reagents, stationeries, instrument/equipment spares, etc.
to avoid failure of any system or process.
To have overall review of the departmental activities at regular interval for continual improvement and updating the system with Head QA/QC.
To impart the technical training at regular intervals for upgrading the skills and awareness to all the employees in co-ordination with QA.
To ensure the appropriate infrastructure as per the cGMP/GLP/respective pharmacopeias requirements are available.
Any such new requirements have to be identified and appropriate
instrument /equipment/system /reagent/standards shall be procured as the organization policies.