Quality Operations / Assurance Specialist (Systems Quality, GMP, Manufacturing)

Quality Operations / Assurance Specialist (Systems Quality, GMP, Manufacturing)

Objective of Role

This position is a member of the Quality Operations (QO) team which is Quality representative and partner for the manufacturing and facility engineering team to ensure GMP compliance at the company.

Responsibilities

1. Quality Systems Representative
   • Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility Engineering.
   • Partner with 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.
2. Routine QO Operations
   • Revise & participate in the development and writing of procedures pertaining to the QO operations.
   • Together with the SME, assist the manufacturing and/or facility engineering team with development and writing of process SOPs and Master Batch Records and ensure that it complies with current good practices and the applicable DMs and regulatory requirements.
   • Own events relating to Quality Operations. Participate in investigations relating to manufacturing/facilities/utilities and assist in the writing and review of the investigation report relating to manufacturing/facility engineering/environmental monitoring.
   • Review of the manufacturing batch records and revision of MBR/MFR/SOP.
   • Participate as SME in the gap analysis for current SOP/practices with the various subject matter experts to ensure compliance with DMs revision; where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion.
   • Participate in cross-function investigations.
   • Support the manufacturing and/or facility engineering team with any quality interpretation, queries, and issues.
3. 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.
   • Build strong partnerships with all other departments to ensure open communications and acceptance.
   • Commitment to a fair and respectful relationship with others and behavior in accordance with the company Code of Conduct.

• Responsibility to adhere to any applicable EHS requirements.
• Any other duties as assigned by supervisor.

Requirements:

1. Min Diploma / Degree in Chemical Process Technology, Food Science, Biotechnology, Biology, Biomedical Sciences, Science or its equivalents.
2. Min 3 years relevant experience in a related industry preferred.
3. Able to start immediately preferred.

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA/QC).

Thank You.

R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)