Full Time Quality Operations Specialist (Pharma-Biotech) Jobs, Salary up to SGD 7,000 in NUSANTARA PRIME CONSULTING PTE. LTD. - Maukerja

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)

Nusantara Prime Consulting Pte. Ltd (NPC)

is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.

Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.

Our Mission

With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.

Our Vision

To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.