Team Leader - QC

Division

Department

Sub Department 1

Job Purpose

Monitor the execution of the analysis request received at the (FP/ RM/ PV/ CV/ ANDA/ PM) sections to ensure that the analysis is completed within stipulated period and in compliance to GxP requirements

Key Accountabilities (1/6)

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

• Monitor the release of individual samples within the stipulated period to meets the service level agreement (SLA) and plant OTIF
• 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

Key Accountabilities (2/6)

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

Key Accountabilities (3/6)

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

Key Accountabilities (4/6)

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

Key Accountabilities (5/6)

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

Key Accountabilities (6/6)

Major Challenges

Key Interactions (1/2)

Key Interactions (2/2)

Dimensions (1/2)

Dimensions (2/2)

Key Decisions (1/2)

Key Decisions (2/2)

Education Qualification

B.Sc. /M.Sc. (Chemistry)

Relevant Work Experience

6-8 years of experience in quality control function of a pharmaceutical organisation. At least 2-3 years of experience leading a team