Quality Operations Specialist (Pharma/Biotech)

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 67,000 - 89,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. is seeking a Quality Operations Specialist to support site management in executing the quality system across manufacturing and production areas.

This role focuses on observing, documenting, and reporting quality events to ensure highest quality and compliance of released batches. Responsibilities include reviewing materials, batch records and logs, releasing batches, and participating in investigations and change management to maintain GxP compliance.

Qualifications

• Diploma in Science, Engineering, Pharmacy or related field.
• Minimum 3 years of pharmaceutical/biopharmaceutical quality/compliance (GxP) experience.
• Experience with SAP or TrackWise preferred.

Responsibilities

• Ensure products meet policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and related activities.
• Review incoming material packages, batch records, manufacturing logs and QA logs.
• Release batches and participate in investigations arising from non-compliance.
• Support change management and QA oversight activities.
• Conduct regular walk-throughs of facilities to ensure ongoing compliance.
• Assist with new product introduction and operation excellence projects.

Skills

Communication skills

Planning skills

Integrity

Quality mindset

Education

Diploma in Science or related fields

Diploma in Pharmacy

Tools

SAP

TrackWise

Job description

Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are 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-through 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

About You:

• Diploma in Science (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
• Minimum of 3 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred
• Ability to quickly know products and processes in order to assess quality issues
• Committed to quality and maintain a high standard of work at all times
• Demonstrates the highest levels of integrity and a strong work ethic
• Good knowledge of GxP requirements and regulations
• Good planning and scheduling skills
• Good communication and interpersonal skills both verbal and written

Duration: 6 months contract. (Option to renew/convert based on performance)