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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
• Quality Systems Representative
o Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility
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
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/DPs 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/DPs 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
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.
• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• Min 5 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 [ Link removed ] (Attn: QA/ QO)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
- Maintain daily operations PHYSICAL SKILLS, ABILITIES, AND EXERTION
- Develop documentation of operations or support procedures
- Assist operations on improvements in plant operations
- Maintaining operations related customer playbook documentation
- Train and or support operations
- Perform duties within the tactical operations center (TOC)
- Work with corporate ad operations
- Represent operations in client meetings
- Supervising a team of operations employees
- Work internal service requests for accounts
- Establish and maintain effective team project service operations communications .
- Produce daily/weekly/monthly reports as well as ad hoc requests to be fulfilled by the operations team
- Provide assistance to loan operations special assets department
- Maintain all operational reports for department
- Set up new customer accounts
- Assist with field specialist training
- Ensuring customer data quality through comprehensive data review
- Ensure effective delivery of global business operations
- Support operations related to processes and inventory
- Provide operational leadership with customer logistics processes
- Quality Assurance
- Quality Control
EA License No.99C4599
EA Personal Registration No.R1551708
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