Quality Assurance Specialist I US MNC I 9-Months Renewable

Location Tuas, Singapore
Discipline Pharmaceutical
Job Reference TC - 589465_1565165161
Salary S$3000 - S$7000 per month + Allowance
Consultant Name Tammy Chew Wen Hui
Consultant Email tammy.chew@manpower.com.sg
Consultant Contact No. 62325246
EA License No. 02C3423
Consultant Registration No. R1877573

Quality Assurance Specialist (9 Months Contract, Renewable)

Our client is a US MNC and a pioneering leader in the Pharmaceuticals industry. They are currently seeking a QA Specialist. The successful candidate will be in partnership with the Quality Manager, providing Quality and Compliance inputs and advice regarding GMP considerations, and taking a leadership role in ensuring compliance to appropriate regulations and corporate standards.

Responsibilities:

  • Support Quality systems including, but not limited to, Validation, Deviation Management, and Change Control.
  • Provide Quality and Compliance expertise for all IPT and site compliance initiatives
  • Support Quality and SHE stewardship activities
  • Lead and drive site Quality culture.
  • Serve as representative for Quality Assurance and compliance program for IPT, which may include Deviation Management, Change Control, Equipment and Process Validation and other quality initiatives.
  • Serve as member of project team with participation in the applicable forums, providing GMP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
  • Proactively identify analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies
  • Review and approve investigation documents. Coach and guide investigation team to ensure investigation is thoroughly conducted and meet the standards set in the SOP.
  • Review and approve Change Control (Equipment, Automation, Process).
  • Support walkdown to ensure compliance and maintain high level of ICSL, LROT, iOTIF.
  • Approve cGMP documentation, including SOP, Job Aids and procedures as Quality approver.
  • Supports IPT compliance programs.
  • Develop a continuous improvement framework within the Quality team, identify and implement projects and improvements, actively supports site improvement programs.
  • Ensure timely closure of deviation and laboratory investigations, change controls, and protocols.
  • Makes decisions - guided by policies and procedures - that impact the department ability to meet performance objectives (i.e. Product disposition).

Requirements:

  • Bachelor's Degree in Science / Life Science, IT or Engineering or proven relevant experience.
  • Relevant experience in a quality assurance and other function (e.g. operations, technical, etc) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA, EMA, PMDA etc.
  • Good working knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
  • Validation and Sterile manufacturing experience preferred.
  • 0 - 7 years of relevant experience.
  • Strong communication skills.
  • Able to work independently and in a team environment.
  • Meticulous with high integrity.
  • Strong organizing and time management skills.
  • Positive attitude and self-motivated.

If you're interested, please send in your application with your detailed and updated resume to Tammy Chew Wen Hui (R1877573) at tammy.chew@manpower.com.sg.

Thank you!

Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573

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