QC Manager at Cipla

Job Purpose

• Lead the overall operations pertaining to the Quality Control Laboratory in relation to staff, quality and operations. Provides high quality service and technical expertise to internal and external customers, and performs the functions associated with the Quality Control Laboratory (excluding Microbiology and Compliance team)

Key Accountabilities 

• People Management  
• Manage the team timekeeping, leaves and overtime. 
• Assist with disciplinary procedures, recruitment and retention of staff. 
• Encourage the teamwork spirit and motivate the team. 
• Communicates effectively with staff, departments & external clients to ensure timeous resolution of queries. 
• Manage the talent and delegate effectively 
• Manage diversity. 
• Undertake project work within the operational objectives of the organization. 

QC Laboratory Management 

• To ensure and increase the efficiency in the QC laboratory. 

QC Systems 

• Ensures that the QC laboratory maintains GMP Compliance, safety standards and good housekeeping  
• Continuous improvement of processes / validation. 
• Accurate assessment of data and decisions taken by QC analysts and microbiologist. 
• Responsible for the final release of all QC test results. 
• Responsible for appropriate action on all QC data through the development and implementation of systems to improve processes and tests. 
• Accurate assessment of laboratory requirements such as equipment and consumables. 
• Review anomalies and propose corrective actions. 
• Communicates effectively with other staff, departments & external clients to ensure timeous resolution of queries. 
• Manage the laboratory maintenance, validation & calibration programme  
• Monitoring routine sampling and analysis of samples. 
• Review and Check the logbooks/Preparation of laboratory solution. 
• Review and approval of analytical reports of chemical testing for batch release 
• Preparation/Review of specifications or monographs. 
• Review of trend reports for APQR 
• Preparation of certificate of analysis for post importation products and providing certificates to customer.  
• To ensure compliance to current guidelines. 
• Ongoing development, evaluation & implementation of quality control testing programmes in conjunction with Regulatory, QA, production and Customers 
• Ensure that appropriate action is taken and prevented in the event of non-compliance (OOS/OOT/Analytical Incidents) 
• Ensure that major deficiencies, errors, deviation from SOP’s, compliance with QC programs and GMP are in line with appropriate measures. 
• Responsible for successful implementation and maintenance of quality control systems in laboratory including CAPA, vendor approval, validation, document control. 
• Survey the environment to keep abreast of latest regulatory requirement so that all documents are in adherence to current GxP systems 

Technical Support 

• To ensure the competency and support to the team or external stakeholders. 

Educational qualifications:  

• Provide direction for continuous improvement and simplification of processes/documentation. 
• Support QC staff and manufacturing to resolve QC related problems. 
• Perform accurate statistical analysis and evaluation of trend analysis on tests & results. 
• Ensure ongoing research, validation & evaluation of test methods, equipment & processes. 
• Ensure that the analyst qualification is conducted. 
• Provide environment to team members to develop their potential by involving them in major discussions/trainings. 
• Oversee troubleshooting on QC laboratory processes and delegate corrective actions to QC personnel. 
• Ensure that the technical/method transfers and method validation 
• BSc Chemistry/Degree Analytical Chemistry (or Equivalent)

Relevant experience:  

• 6-8 years of experience in QC department of a pharmaceutical organization with knowledge of latest regulatory standards and compliance norms