Job Title :
Manager/ Assistant Manager
Job Location :
Well versed in generation, maintenance and review of SOPs, procedures, training, and other documentation systems.
Must have handled compliance check of ISO 17025:2005, related regulatory requirements throughout the lab.
Preparation of Master Validation Plan, Quality Manual, Site Master File.
Preparation of documents like Management System Documents (Quality Manuals, Business Continuity Plan, Master Validation Plan, Organogram etc.), Management System Procedures and Standard Operating Procedures. Preparation of Master Validation Plan. Review of method development and validation protocols and reports of Leachable / extractable, Genotoxic impurities, gum and ink migration study etc. as per ICH Q2, WHO guidelines
Preparation of Training Modules and give training to new and existing staff.
Record and investigate complaints from the Customers, investigate the complaint to find out the root cause. Document respective investigation and Corrective Actions report.
Conduct internal audits and special audits of various divisions, facilities, suppliers and vendors. Prepare audit observations and audit report.
Preparation of Internal Quality Audit Plan and selection of auditors
NABL (National Accreditation Board for testing and calibration Laboratory)
Minimum of 4 years' experience in healthcare training and curriculum development.
Master degree (Full Time).
Familiar with SOP preparations and audit.
Ability to work both independently and as part of a team.
Excellent problem solving and customer service skills.
Excellent verbal and written communication skills.
Flexible with ability to adapt quickly to evolving situations.
Strong interpersonal skills; able to deal effectively with customers, vendors, peers, and management.
Technically adept; able to learn new processes and tools quickly.
Willingness to travel locally to various clinics.