Pharma Quality Assurance Specialist (Compliance/ Auditor)

Recruit Express Pte Ltd | Date Posted: 17-Jul-2018
EA Licence No: 99C4599 | EA Personal Registration No: R1551708
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Qualification:
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

  • 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 or Degree in Biomedical Sciences, Biotechnology, Life Sciences or any science related fields
  • Min 5-10 years experience in a pharma manufacturing company
  • Knowledge of GMP guidelines
  • 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 [Click Here to Email Your Resume]  (Attn: QA - Leon)



Thank You.


Leon Leong De Cong
R1551708

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


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Recruit Express Pte Ltd