QC Supervisor Lab

Accountability Cluster

Major Activities / Tasks

I. Plan the daily allocation of the routine analysis and ensure the completion of pending work to achieve the service level agreement (SLA)

• Monitor the release of individual samples within the stipulated period to meets the service level agreement (SLA)
• Check and confirm the availability of required specifications, TDS, chemicals, reagents, impurities, column standards, specification and other requirements by verifying it with stock to perform the analysis
• Observing and complying with Good Manufacturing practices (GMP).
• Operate the instruments and perform the activities as per SOP and safety norms.

II. Monitor the lab activities for adherence to standard and valid procedures by online review to execution of overall activities in the section in compliance to the predefined quality standards and cGMP requirements

• Review of draft copy of new specification, test data sheet, IOP, SOP, EOP etc.
• Review, compile and release analytical reports of FP/RM/PV/CV and ensure submission of reports to LAB QA for final release as per service level agreement
• Ensure all necessary approved SOPs are in place at the section as per current requirements

III. Monitor and execute the investigation of the batch for non-conformance and ensure its closure within the timelines defined in SOPs to rule out the assignable cause of error

• Minimize the in-valid OOS/OOT and other non-conformances in laboratory by conducting RCI
• Resolve the queries and problem online to individuals to ensure the timely completion of all the task planned
• Investigate the OOS, OOT or any deviation by verification of initial sample, experimentation design, and repeat analysis as per requirement

IV. Resolve the queries and problems faced by the individuals in the team by providing the technical support to ensure the timely completion of all the task planned

• Conduct handshake meetings, daily PD with production planning for release, commitment, issues etc. by coordinating with CFTs
• Provide the schedule for training for personal validation of new entrant in section to explore the SOP contents and requirements
• Handshake with production planning, store, dispatch to track the product status and track status of missing sample
• Propose and perform validation to achieve improvement of methods

V. Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification

• Identify new ideas and procedures that can be implemented in the sections to achieve the work simplification and cost savings
• Strive for continuous automation of processes through implementation of new processes.

• Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities
• Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers
• Delay in releasing the batches due to non-availability of approved samples for PM on time. Overcome by coordinating with CFTs and escalations   
• Identifying the exact root cause for the non-conformance before its closure. Overcome by providing technical guidance and preparing the schedule of every NC to complete every activity within time frame

Internal

External

• Unit Planning for daily release of RM,PM and FP (Daily)
• Packaging and repacking for PM related issues (Need Basis)
• Unit QA for non-conformances (Need Basis)
• Stores for inventory (Daily)
• Purchase for samples, consumable, reagent etc (Weekly)

• Service Engineer to resolve instrument related issues, breakdown (Need Basis)

• Number of FP batches released: 20 Batches/month.
• Non-conformance OOS/OOT to be closed within 30 working days.
• Master approval for specifications and stability studies
• Manpower utilisation
• Shifting of analysts to fulfil urgencies