Quality Operations Specialist (QA/ Pharma/ 6 Month Contract)
6-Months Contract
Location: Tuas
Salary: Up to $5500 depending on experience
Our client, a MNC company in BioPharmaceutical Industry is currently looking for Quality Operations Specialist
Primary Function:
- Assist site management to oversight the quality system execution on the manufacturing and production areas at all times.
- Required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product.
- Responsible to ensure highest quality and compliance of released batches
Responsibilities:
- Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, processes and procedures.
- Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
- Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out.
- Release incoming material, process, and product batches.
- Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
- Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
- Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
- Participate and support new product introduction, operation excellence projects and other tasks as assigned by management.
Requirements:
- Bachelor Degree in Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
- Knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
- Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- Experience in SAP, Trackwise
Lim Pey Chyi (Apple) - [Confidential Information]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Desired Skills and Experience
Bachelor Degree in Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
Knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
Experience in SAP, Trackwise
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579
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