Section Head - QC

Division

Department

Sub Department 1

Job Purpose

Plan and lead the quality control routine operations and stability studies and drive the team to confirm testing as per the GLP guidelines and regulatory requirements and achieve timely release of batches and SRB targets to meet unit OTIF

Key Accountabilities (1/6)

Plan the quality control routine operations and stability studies in order to ensure timely completion of stability studies and smooth functioning of release activity

• Monitor the commitment dates for release of RM, PM, FP & water analysis and process/cleaning validation section by conducting performance dialogues and handshake
• Review the plans prepared and monitor timely execution of activities in all the shifts to avoid delays
• Review the monthly planner and production plans to ensure timely availability of required resources and ensure no sample is overdue

Key Accountabilities (2/6)

Monitor the execution of all routine quality control operation and stability studies to ensure timely delivery and meet regulatory requirements and cGMP, GLP guidelines

• Monitor routine/stability operations closely and ensure that all necessary SOPs are followed by the team
• Provide technical guidance related to troubleshooting in chromatography, experimentation design etc. to minimize non-conformances
• Monitor timely implementation of new updates in specifications and QCPs to meet compliance
• Perform online review of reports generated to ensure zero data integrity issues in Lab
• Monitor sample charging and sample pull-out as per schedule
• Monitor reserved samples storage and destruction as per schedule and perform UD release
• Monitor the stability chamber daily for excursions and other related issues

Key Accountabilities (3/6)

Drive the investigation of the batch for non-conformance and ensure its closure within the  timelines defined in SOPs to facilitate smooth operations

• Evaluate root cause analysis in case of OOS, OOT, incidences and rejection and propose CAPAs
• Investigate the stability chamber excursions and propose CAPAs
• Ensure that all non-conformances are routed  through proper channel and are investigated as per SOP
• Communicate with respective QC/QA heads for compliance and ensure timely closure of CAPAs by tracking in SmartSolve

Key Accountabilities (4/6)

Monitor completion of stability studies as per protocol/schedule to avoid delays in product launch

• Perform analysis for stability samples without any errors as per schedule
• Ensure timely completion of ANDA samples testing and submission of data by verifying it with ANDA schedule
• Plan the routine/stability activities by coordinating with ADL/R&D about dates of product dossier filing
• Resolve analytical and product related issues by escalating to ADL, R&D and transfer unit

Key Accountabilities (5/6)

Provide technical guidance to the team w.r.t batch release and stability studies and evaluate their performance to ensure team development and improved lab efficiency

• Identify the training needs of employees based on the updates in the pharmacopeial guidelines
• Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP
• Monitor the productivity of all the teams in the section by reviewing %SLA and %NC rates
• Ensure the completion of training and qualification of analyst by taking feedback and timely reviewing his work

Key Accountabilities (6/6)

Major Challenges

• 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

Key Interactions (1/2)

• Unit Planning for daily release of RM,PM and FP (Daily)
• CDC for specification changes implementation (Need Basis)
• ADL for method related issues, analytical incidences (Need Basis)
• Packing Development for PM related issues (Need Basis)
• Unit QA / CQA  for non-conformances (Need Basis)
• Stores for inventory (Daily)
• Purchase for approved samples (Weekly)

Key Interactions (2/2)

• Service Engineer to resolve instrument related issues, breakdown (Need Basis)
• Outside Labs for sample analysis (Need Basis)
• RM/PM Supplier for deliveries (Monthly)

Dimensions (1/2)

• Direct Reports : 13-17
• Team Size : 13-17
• Number of FP batches released:
• Number of RM analysis conducted :
• Number of studies conducted for Stability samples :
• Number of ANDA studies performed :
• Non-conformance OOS/OOT to be closed within XX working days
• Non-conformance rate should be below

Dimensions (2/2)

Key Decisions (1/2)

• Master approval for specifications and stability studies
• Manpower utilisation
• Shifting of analysts to fulfil urgencies

Key Decisions (2/2)

• Simplification of SOPs to Unit Head – QC
• Suggestions for improvement of QC productivity to Unit Head – QC
• Implementation of CAPAs to reduce non-conformances to Unit Head – QC
• Improvement of work bench practices to Unit Head – QC 

Education Qualification

B. Sc. / B. Pharm.

Relevant Work Experience

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