Technical Manager - Drug Testing Lab

Qualichem Laboratories

Nagpur District

On-site

INR 800,000 - 1,400,000

Full time

5 days ago
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Job summary

Qualichem Laboratories in Nagpur district seeks an experienced Laboratory Manager to lead quality assurance, compliance, and daily lab operations. You will oversee SOP development, regulations adherence, audits, CAPA, and performance analytics.

The role requires strong leadership, mentoring, budgeting input, and collaboration with QA, Production, and Regulatory teams to drive efficiency and ensure data integrity across testing activities.

Qualifications

  • Provide technical guidance to laboratory staff on analytical methods, instrumentation, and data interpretation.
  • Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions for all testing activities.
  • Oversee the validation and verification of analytical methods, ensuring their suitability for intended use.
  • Manage the maintenance, calibration, and qualification of laboratory equipment and instruments.
  • Troubleshoot technical issues and implement corrective and preventive actions (CAPA).
  • Stay abreast of the latest advancements in analytical techniques and regulatory requirements.

Responsibilities

  • Ensure the laboratory operates in compliance with relevant regulatory guidelines (e.g., GMP, GLP, ISO 17025) and company quality standards.
  • Participate in internal and external audits and implement necessary corrective actions.
  • Manage the laboratorys quality control program, including the monitoring of critical quality parameters.
  • Maintain accurate and complete laboratory records and documentation.
  • Contribute to the development and implementation of the laboratorys quality management system.
  • Supervise, mentor, and evaluate the performance of laboratory analysts, technicians, and other technical staff.
  • Assign tasks, set priorities, and ensure efficient workflow within the laboratory.
  • Identify training needs and facilitate the professional development of team members.
  • Foster a positive and collaborative work environment.
  • Conduct regular team meetings and communicate effectively with staff.
  • Monitor laboratory performance metrics and identify areas for improvement in efficiency and turnaround time.
  • Implement lean laboratory principles and process optimization initiatives.
  • Manage laboratory resources effectively, including consumables, reagents, and equipment.
  • Contribute to the budgeting process and ensure cost-effective operations.
  • Prepare and present technical reports, summaries, and data analysis to management.
  • Communicate effectively with internal stakeholders (e.g., Quality Assurance, Production, Regulatory Affairs) and external clients.
  • Participate in project meetings and provide technical input.

Skills

Laboratory management
SOP development
Regulatory compliance
CAPA
Audit & quality
Team leadership
Data interpretation
Process improvement
Budgeting & cost control
Communication

Tools

Equipment calibration

Job description

  • Provide technical guidance and expertise to laboratory staff on analytical methods, instrumentation, and data interpretation.
  • Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions for all testing activities.
  • Oversee the validation and verification of analytical methods, ensuring their suitability for intended use.
  • Manage the maintenance, calibration, and qualification of laboratory equipment and instruments.
  • Troubleshoot technical issues and implement corrective and preventive actions (CAPA).
  • Stay abreast of the latest advancements in analytical techniques and regulatory requirements.
Quality Assurance and Compliance:
  • Ensure the laboratory operates in compliance with relevant regulatory guidelines (e.g., GMP, GLP, ISO 17025) and company quality standards.
  • Participate in internal and external audits and implement necessary corrective actions.
  • Manage the laboratorys quality control program, including the monitoring of critical quality parameters.
  • Maintain accurate and complete laboratory records and documentation.
  • Contribute to the development and implementation of the laboratorys quality management system.
Team Management and Development:
  • Supervise, mentor, and evaluate the performance of laboratory analysts, technicians, and other technical staff.
  • Assign tasks, set priorities, and ensure efficient workflow within the laboratory.
  • Identify training needs and facilitate the professional development of team members.
  • Foster a positive and collaborative work environment.
  • Conduct regular team meetings and communicate effectively with staff.
Operational Efficiency and Improvement:
  • Monitor laboratory performance metrics and identify areas for improvement in efficiency and turnaround time.
  • Implement lean laboratory principles and process optimization initiatives.
  • Manage laboratory resources effectively, including consumables, reagents, and equipment.
  • Contribute to the budgeting process and ensure cost-effective operations.
Reporting and Communication:
  • Prepare and present technical reports, summaries, and data analysis to management.
  • Communicate effectively with internal stakeholders (e.g., Quality Assurance, Production, Regulatory Affairs) and external clients.
  • Participate in project meetings and provide technical input.

Standard operating procedures,quality assurance,internal audit,auditing,internal control,internal control review,enterprise risk management,sox compliance,business process review,risk management,risk assessment,gmp,software testing,sop,production

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