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

• Quality Systems Representative
o Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility
Engineering.
o Partner the manufacturing and/or facility engineering team and helping with implementation and adherence to the various Quality systems and GMP requirements at the manufacturing suite
o Lead/organise sessions/meetings for the manufacturing and/or facility engineering team for information learning & sharing and alignment of best practices
o Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by Supervisor

• Routine QO Operations
o Revise & Participate in the development and writing of procedures pertaining to the QO
operations.
o 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.
o Own events relating to Quality Operations. Participating 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.
o Review of the manufacturing batch records and revision of MBR/MFR/SOP.
o Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DMs revision, where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion.
o Participate in cross-function investigations
o Support the manufacturing and/or facility engineering team with any quality interpretation,
queries and issues

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

• Leadership

o Build strong partnership with all other departments to ensure open communications and acceptance o Commitment to a fair and respectful relationship to 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:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents

• Min 3 years relevant experience in a related industry preferred

• 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.

Leon Leong De Cong

R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)


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