nSupporting in-process control sample testing by online analysis to support production activities
nSampling, analysis and ascertaining quality of intermediates, In-process samples and API for Chemistry Ankleshwar.
nTesting of the method validation samples and process validation samples and cleaning validation.
nPerform analysis and documentation of API finished product stability study as per stability study protocol.
nCoordinating with Production, CWH and QA for Approval / Rejection of raw materials/finished product.
nValidation and verification of analytical procedures as per requirement.
nReporting OOS / OOT results and deviations.
nMaintaining retained samples as per standard procedure.
nAssisting in investigation of customer complaint.
nTesting of new samples (Vendor approval)
nGive required suggestion for corrective actions and to plan effective preventive actions for the up gradation of the quality system.
nTo ensure proper maintenance of the stability samples and their management.
nDisposal of waste according to the approved procedures.
nContinual reduction in the waste generation and effluent management.
nCo-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities.
nGeneration, managing and archiving Documents including raw data, reports, COA etc as per requirements.
nPreparation and implementation of the SOPs in the laboratories system.
nSpecification preparation and implementing for API raw material and API finished product according to requirement.
nMaintaining LIMS data entries
nProviding technical support in compiling Annual Product Review.
nAnalytical method development when required.
nExecuting on line documentation
nQualification and Validation of instruments/equipment
nAppropriate training and guidance to the subordinates.
nSafety in the laboratory.
nRegular housekeeping and upkeep of the work area.
nMaintaining adequate inventory of chemicals and reference standards.
nAdapting relevant technologies and systems in Quality control.
nLaboratory equipment calibration and their maintenance.
nGenerate up gradation plans as need basis.
nAny other activity assigned by the In-charge, Quality control
nQuality, HSE and Compliance
nAdhere to current GMP guidelines
nFollowing ALCOA+++ practices during documentation and related activities
nCompliance to local and international HSE norms
nISO 14000 related activities
nRegular Pharmacopoeia and regulatory requirement review for compliance
nTo participate in any regulatory/Customer inspection takes place at the site
nTraining of self and subordinates on quality and HSE systems
nMember of validation team.
nParticipating in discussions and giving feedback to Manager, Quality control regarding on-going activities.
nTrouble shooting activities.
nIdentifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations
nPlant round in absence of QA and during IInd and IIIrd shift.
nOnline checking of critical process parameters during round.
