Quality Operations Specialist (Pharma/ 6 months contract)

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Part time

Job summary

Manpower Staffing Services (Singapore) Pte Ltd in Singapore is seeking a Quality Operations Specialist for a 6-month contract at the Tuas site. The role focuses on overseeing quality system execution across manufacturing and production areas and reporting quality adverse events.

You will release batches, review batch records, participate in investigations, change management, and support new product introductions and operations excellence initiatives.

Qualifications

• Minimum of 2+ years in pharma/biopharmaceutical Quality & Compliance (GxP).
• Knowledge of quality/compliance management and APIs/biologics regulations.
• Experience with SAP and TrackWise.

Responsibilities

• Assist site management to oversight the quality system execution on the manufacturing and production areas at all times.
• 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.

Skills

Quality Assurance

GxP Compliance

Regulatory Knowledge

Education

Bachelor's Degree in Natural Sciences/Pharmacy/Engineering

Tools

SAP

TrackWise

Job description

• 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.