Job Description

Description

Salary: up to $4500

Working Days & Hours: Mon-Fri Office Hours

Location: Ubi

:

\xc2\xb7 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.

\xc2\xb7 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.

\xc2\xb7 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.

\xc2\xb7 Assist in tracking of QA audits, inspections and procedures, as applicable.

\xc2\xb7 Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May host client site visits.

\xc2\xb7 Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.

\xc2\xb7 Support the execution of corporate compliance assessments/mock-agency inspections of other sites.

\xc2\xb7 Coordinate and facilitate site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members.

\xc2\xb7 Participate in the preparation of support during regulatory inspections, as required.

\xc2\xb7 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.

\xc2\xb7 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.

\xc2\xb7 Perform facility and equipment records and logbook reviews.

\xc2\xb7 Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.

\xc2\xb7 Support or conduct process based inspections as deemed necessary.

\xc2\xb7 Assist in identification of any regulatory risk areas.

\xc2\xb7 Assist with reporting, analysis and collection of site Quality Metrics via QMS.

Quality Management Review (QMR) and support during the QMR.

\xc2\xb7 Provide process-improvement recommendations for dashboard analysis and analyze metric data for QMS.

\xc2\xb7 Participate in coordination of Quality Assurance projects.

\xc2\xb7 Assist with providing basic regulatory training to QA and operations personnel.

\xc2\xb7 Provide timely responses to Customer inquiries to support their qualification / regulatory requests.

\xc2\xb7 Perform all other related duties as assigned.

Job Requirements: Min Degree in Science or similar with min 5 years of relevant exp in Pharma industry

Interested candidates, please submit your resume to: allylok@recruitexpress.com.sg

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

allylok@recruitexpress.com.sg

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device

Specialization

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

Location

East

Employment Type

Permanent

Salary

S$2,601 - S$4,000 / mth
S$4,001 - S$6,000 / mth

If you meet the requirements of this role, please email a detailed resume in Word document to Audrey Lok Xin Woon (Ally).
CEI Registration No.: R21102307
Email: allylok@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