Quality Operations Specialist (QA/ Pharma/ 6 Month Contract)

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) - Sign in to view email

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

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