Quality Operations Specialist (Pharma/ 6 months contract)

• Duration: 6 months contract with an option to extend
• Work location: Tuas

About the Job
Our client, a MNC company in BioPharmaceutical Industry is currently looking for Quality Operations Specialist

• Assist site management to oversight the quality system execution on the manufacturing and production areas at all times.
• 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 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 a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
• Experience in SAP, Trackwise
• Good interpersonal skills.

Ramos May Anne De Mesa - [email protected]

Personnel Reg No: R1110127

Manpower Staffing Services (S) Pte Ltd

EA Licence No: 02C3423