Job Description

Description

• 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.
• Provide recommendations to Operations and Quality Management for improvements in auditing of quality systems based on knowledge and understanding of current regulatory inspection guidance and internal trends.
• Assist in tracking of QA audits, inspections and procedures, as applicable.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May host client site visits.
• Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
• Support the execution of corporate compliance assessments/mock-agency inspections of other sites.
• Coordinate and facilitate 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.
• Independently perform 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.
• 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.
• Perform facility and equipment records and logbook reviews.
• Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
• Support meeting the review requirements for Customer or Supplier related Quality Agreements
• Support or conduct process based inspections as deemed necessary.
• Assist in identification of any regulatory risk areas.
• Assist with reporting, analysis and collection of site Quality Metrics via QMS.
• Assist with preparations for Quality Management Review (QMR) and support during the QMR.
• Provide process-improvement recommendations for dashboard analysis and analyze metric data for QMS.
• Participate in coordination of Quality Assurance projects.
• Assist with providing basic regulatory training to QA and operations personnel.
• Provide timely responses to Customer inquiries to support their qualification / regulatory requests.
• Perform all other related duties as assigned.

Requirements

• Min Bachelor\'s degree or equivalent, preferably in a life science.
• Minimum of 3-4 years in a Quality Assurance role
• GMP systems knowledge with Supplier Quality Management concept
• Will require the personnel to reach out to supplier or support the senior supplier qual specialist to support documentation compilation and GMP review per procedural requirement
• Knowledge of DMS (documentation management systems) general knowledge to support doc center activities if required

For interested candidates, please send your most recent and updated resume to michelle.lee@recruitexpress.com.sg
Subject heading: QSS

Michelle Lee Ser Min
Recruit Express Pte Ltd
(R1440070)
EA Licence No. 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

Chemist / Research Scientist
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs

Location

East

Employment Type

Permanent

Salary

Negotiable

If you meet the requirements of this role, please email a detailed resume in Word document to Michelle Lee Ser Min.
CEI Registration No.: R1440070
Email: michelle.lee@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express