Perm MNC Microbial & Biological Testing (Pharmaceutical Company) - Professional Development Opportu

Quality Systems Specialist I

Mon-Fri: Office hour

Job Descriptions:

• Assure compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions.  Communicate all identified compliance and quality risks to supervisor.
• Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations. 
• Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.
• Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. 
• Participate in the execution of  site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members.
• Participate in the preparation of support during regulatory inspections, as required.
• Participate in the performance of internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Perform facility and equipment records and logbook reviews.
• Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
• Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members.
• Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
• Assist with analysis and collection of site Quality Metrics via QMS.
• Assist with preparations for Quality Management Review (QMR).
• Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS. 
• Participate in execution of Quality Assurance projects.
• Assist with providing basic regulatory training to operations personnel.
• Provide timely responses to Customer inquiries to support their qualification / regulatory requests.
• Perform all other related duties as assigned.

Requirements:

• Bachelor’s degree (B.S. / BA.A.) or equivalent, preferably in a life science. (No Exp welcomed).
• Some experience with Microsoft Office® applications.
• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. 
• Must regularly communicate with employees/customers; must be able to exchange accurate information.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• May occasionally be required to wear protective clothing and equipment.

WhatsApp: wa.me/6596892303

Wang Chloe | R23118712
RecruitFirst Pte Ltd (13C6342)