The role of team leader in pharmaceutical QC and AR&D

 The job of the leader is to grow. Grow in knowledge, patience, consistency and sympathy. The role of team leader is very crucial in achieving error free execution in quality control. Team leader not only allocates work or reviews document but also helps on remedial action plan to come out of the errors that have happened during experiment. The quality of data generated is dependent on system & procedures but more often on the mindset of a leader. Many times, the flaw in the system leads to non conformities. The job of the leader is to identify such flaw immediately and put mitigation plan in action to avoid further damage. There is likely any chance of data integrity issue once the system is perfected and people are trained. Pharmaceutical companies’ pays high attention towards data integrity issue as it has direct impact on company’s reputation, market share and business potential. With ever increasing regulatory demand, it is also important for pharmaceutical companies to devise their own strategies to meet them. The regulatory demands can only be met if there is a harmony within and outside team. No doubt, the front line leaders or managers are going to play a vital role in meeting all these requirements. And hence it is important for group leaders or managers to understand their role on new ground.  

Below are the critical steps group leader must consider while working in a quality control

1.     Sample receipt details: The journey of any sample in QC lab starts with sample receipt and ends with sample destruction. During sample receipt, the deputed chemist must verify physical condition of sample, labeling of sample, packaging of sample etc. The ARR details must be cross verified with the sample labeling details. There must be provision available to record the discrepancies if any found during the examination of sample. The group leader must help in preparing a checklist including all necessary checks so that none of the details pertaining to sample receipt will be missed. 


2.     Work allocation: The true success of execution lies in timely work allocation to the right chemist. Group leader must allocate the work at least one day in advance so that chemist can mentally get prepared and even can get well versed with the requirements. Group leader must also assess the competency of chemist before allocating work. The competency of chemist is beyond analyst qualification and group leader must be able to measure it based on fact.   


3.     Execution & intermediate review: This is the core part of analysis. Group leader must make all the required resources available to chemist for focused execution, error free documentation and timely delivery. The group leader must keep check on important steps of analysis. Few examples of intermediate checks are as below

a.     Review of weights taken during analysis (chemicals & reagents, standards, samples etc).

b.     Review of sequence in case of chromatographic analysis

c.     Review of instrument method

d.     Review of chromatographic pattern and system suitability

e.      Review of record of analysis

f.      Review of logbooks of instruments/equipments

4.     Review of analytical data: Once the analysis is completed and results are calculated, it is the job of a leader to get hold of entire analytical data for further assessment. This is the most important step in terms of identifying and correcting any error that has happened. During review the focus is of utmost importance. It require good amount of focus to identify error in analytical data. The group leader can also develop smart tactics to review the data quickly. For example, the peak area for standard can be kept handy near the desk for easy reference to identify whether the current analysis area matches to it.

5.     Release of the report: Upon successful review and corrections if any, the report can be released. The raw data along with COA must be handed over to QA for further storage. A dedicated archival room is always preferred to store the data.  

6.     Control sample storage: The control sample must be kept one year after the expiry of the batch. The control sample helps in investigation in case of dispute or during any other need. The control sample must be stored at designated storage condition. The group leader must ensure the required records and proper storage of the control sample.

7.     Implementation of QMS: The group leader must be well acquainted with the implementation of necessary quality management systems such as OOS, OOT, Change Control, Incident etc. The investigation of root cause plays vital role in defining corrective and preventive action and hence group leader must be well versed with investigation process.

8.     Implementation of calculation sheets: Automated calculation sheet ease the calculation process and hence group leader must design and implement the same. This also helps in time saving and further increasing team’s throughput.

9.     Team Building: Group leader must get involved in team building. Group leader must enable employees to learn from others and develop new skills. Working in a team helps employees take on leadership roles and see their team members fulfill their responsibilities.

10.  New initiatives at work place: One crucial skill that can serve you well in both your personal and professional life is the ability to show initiative at work. If you constantly wait to be told what to do, then you waited too long. The habit of initiative entails seeing something that needs to be done and either doing it or figuring out ways to do it. The more you work on initiative, the easier it becomes. The key is finding ways to be resourceful and taking action or doing something before others do it or before you are told to do it. Taking initiative shows the hallmarks of a leader in the making.

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