Recruit Express Pte Ltd. | Quality Assurance

4 weeks ago


Singapore Recruit Express Pte Ltd. Full time

Quality Assurance (QA/ QO Specialist (Pharma MNC, Office Hours 5 days, Training Provided)
Job Description
1. Quality Assurance Specialist Job Description
Reporting to QA Supervisor
Objective of Role

  • This position is part of the Quality Assurance team responsible for implementation and maintenance of the various Quality Systems and release of incoming material to achieve the site objectives for the company.
  • To build up a pipeline of skilled manpower for Singapore’s biologics manufacturing industry.
    Responsibilities

Participating in investigations relating to laboratories/ incoming material release/ systems and review the investigation report.
Support the compliance, audit, regulatory and training activities as required and any other responsibilities as assigned by Supervisor.
Build strong partnerships with all other departments to ensure open communications and acceptance.
Commitment to a fair and respectful relationship to others and behavior in accordance with the company Code of Conduct.
Adhere to any applicable EHS requirements.
Any other duties as assigned by supervisor.
Other responsibilities:
• Quality System(s) implementation and maintenance (if assigned)
• Participate in Quality System(s) rollout by ensuring that the following elements of the Quality System(s) are implemented and maintained at the site according to regulatory, corporate and division requirements:
• Nonconformance/CAPA, Change control, Incoming Release, Quality Management Review, Customer complaints, Annual Product Review/Product Quality Review, Product Recall
• Responsible for the development and writing of Quality systems and QA related procedures.
2. Quality Operations Specialist Job Description
Objective of Role
This position is a member of the Quality Operations (QO) team which is the Quality representative and partner for the manufacturing and facility engineering team to ensure GMP compliance at the company.
Responsibilities
Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility Engineering.
Partner the manufacturing and/or facility engineering team and help with implementation and adherence to the various Quality systems and GMP requirements at the manufacturing suite.
Lead/organise sessions/meetings for the manufacturing and/or facility engineering team for information learning & sharing and alignment of best practices.
Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by Supervisor.
Other responsibilities (if assigned)

  • Render support for timely release of bulk BDS and resolution of BDS release matters.
  • Provide QO related Impact Assessments for Change Controls and own Change Controls (relating to Quality Operations).
  • Lead/Participate in routine GMP walk-through with manufacturing and/or facility engineering team.
  • Participate in all process improvements/studies with Technical Services and the manufacturing team and draft test scripts/protocols.
  • Proper and timely archival of QO documents.
  • Manage Cell Bank and BDS Retention Samples.
    Requirements:

Min Diploma / Degree in Chemical Process Technology, Food Science, Biotechnology, Biology, Biomedical Sciences, Science or its equivalents.
No Experience Needed, Full training/on the job guidance will be provided.
Candidates with internship experience/1 year experience would be at an advantage.
Able to start immediately preferred.
If you are interested in any of the positions, do kindly drop your most updated resume to

(Attn: QA/ QO - Leon)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
#J-18808-Ljbffr



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