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Quality Assurance Specialist (Pharmaceutical MNC, Medical Healthcare Sector) at

Quality Assurance Specialist (Pharmaceutical MNC, Medical Healthcare Sector)

Central Area Permanent

·         Provides guidance and support to innovations processes to meet GCP and regulatory requirements in the conduct of clinical trials.

·         Assists in hosting Sponsor and regulatory inspections and conducts internal,
site, and vendor audits as assigned.

·         Works closely and effectively with Development Innovations, Quality Management, Research Directors, clinical trial Sponsors, clinical study teams, site colleagues, and outside consultants.

·         Providing guidance to research operations on the interpretation of regulatory requirements (standard/ policies/ procedures) related to quality assurance and GCP

·         Performing quality functions and executing quality programs to support CRO processes

·         Assisting in the preparation, hosting, and follow-up of Sponsor audits/ assessments and regulatory inspections

·         Participating in the development and/ or review of standards, policies, procedures, and work instructions to support the quality management system and CRO processes

·         Conducting internal, vendor, and site audits, including planning, executing, reporting, follow-up

·         Providing guidance and support for deviations and corrective and preventive actions required by CRO activities

·         Developing quality plans and/ or audit schedules as appropriate

·         Identifying areas of deficiency and trends in quality and escalating to appropriate colleagues

·         Developing, modifying, and utilizing tools to track and trend compliance issues

·         Developing timelines to ensure timely and appropriate follow-up in areas of deficiency

·         Maintaining records to support quality processes and audits

·         Educating, training, and mentoring staff in quality improvement methods

·         Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends

·         Participating in divisional improvement efforts

Requirements:

  • Min of  Diploma in Biomedical Sciences, Biotechnology, Life Sciences or any science related fields
  • No experience needed, Full training will be provided
  • All are welcome to apply!
  • Relevant experience will be an advantage
  • Excellent communication skills is a must
  • Good management skills of team

If you are interested in the position, do kindly drop your most updated resume to [ Email address blocked ]   (Attn: QA)

 

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599



·         Provides guidance and support to innovations processes to meet GCP and regulatory requirements in the conduct of clinical trials.

·         Assists in hosting Sponsor and regulatory inspections and conducts internal,
site, and vendor audits as assigned.

·         Works closely and effectively with Development Innovations, Quality Management, Research Directors, clinical trial Sponsors, clinical study teams, site colleagues, and outside consultants.

·         Providing guidance to research operations on the interpretation of regulatory requirements (standard/ policies/ procedures) related to quality assurance and GCP

·         Performing quality functions and executing quality programs to support CRO processes

·         Assisting in the preparation, hosting, and follow-up of Sponsor audits/ assessments and regulatory inspections

·         Participating in the development and/ or review of standards, policies, procedures, and work instructions to support the quality management system and CRO processes

·         Conducting internal, vendor, and site audits, including planning, executing, reporting, follow-up

·         Providing guidance and support for deviations and corrective and preventive actions required by CRO activities

·         Developing quality plans and/ or audit schedules as appropriate

·         Identifying areas of deficiency and trends in quality and escalating to appropriate colleagues

·         Developing, modifying, and utilizing tools to track and trend compliance issues

·         Developing timelines to ensure timely and appropriate follow-up in areas of deficiency

·         Maintaining records to support quality processes and audits

·         Educating, training, and mentoring staff in quality improvement methods

·         Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends

·         Participating in divisional improvement efforts

Requirements:

  • Min of  Diploma in Biomedical Sciences, Biotechnology, Life Sciences or any science related fields
  • No experience needed, Full training will be provided
  • All are welcome to apply!
  • Relevant experience will be an advantage
  • Excellent communication skills is a must
  • Good management skills of team

If you are interested in the position, do kindly drop your most updated resume to [ Email address blocked ]   (Attn: QA)

 

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

 

Recommended Skills

  • Assessments
  • Audit Planning
  • Auditing
  • Biotechnology
  • Clinical Trials
  • Communication

EA License No.

99C4599

EA Personal Registration No.

R1551708
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