Posted:1 month ago|
Platform:
Work from Office
Full Time
* 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
Qualichem Laboratories
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