Quality Operations Specialist (Pharma/ 6 months contract)

Manpower Staffing Services (Singapore) Pte Ltd; Santo Niño 1st; On-site; PHP 3,286,000 - 4,928,000; Full time

Job summary

Manpower Staffing Services (Singapore) Pte Ltd seeks a Quality Operations Specialist for a 6-month contract at our Tuas site. The role focuses on overseeing the quality system in manufacturing and production, reporting adverse events, and ensuring batch quality.

The candidate will review materials, batch records, and change management activities, and participate in investigations and continuous improvement projects within a biopharmaceutical QA environment.

Qualifications

• Bachelor degree in a natural sciences field, pharmacy, or engineering.
• Minimum 2+ years of pharmaceutical/biopharmaceutical QA/compliance experience.
• Knowledge of quality/compliance management and API/biologics regulations.

Responsibilities

• Oversee quality system execution in manufacturing and production areas.
• Document, discuss and report quality adverse events.
• Release incoming material, process, and product batches.
• Review materials, batch records, manufacturing logs, and quality logs (QA Hold, QA tag out).
• Assist investigations arising from non-compliance in materials, testing, manufacturing, warehousing, and product.
• Participate in change management to ensure policy compliance.
• Walk through manufacturing, engineering, warehouse and QC areas to maintain compliance.
• Support new product introductions and operation excellence projects.

Education

Bachelor 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.

Ramos May Anne de Mesa EA License No.: 02C3423 Personnel Registration No.: R1110127