Total 2 quality assurance engineer job vacancies in Quality Assurance / Control category in Singapore

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Ensure products manufactured meet approved company policies, processes and procedures
• Provide quality oversight of GMP manufacturing and 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 polices
• 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 team
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent
• Minimum 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/ or Compliance (GxP) environment
• Knowledge of quality/ compliance management as well as regulations and standard affecting APIs/ Biologics
• Ability to quickly know products and processes in order to assess quality issues
• Experience in SAP, Trackwise
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
• Excellent communication skills, both written and verbal, in English

Job Description:

- Contribute to Life Science projects for Antaes Asia clients

- Ensure adherence to the Change Control management systems and processes

- Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed

- Evaluate Change Control requests for process, validation, regulatory and product impact

- Coordinate the review and approval process of change requests to ensure timely execution of changes

- Ensure all site changes are managed appropriately to meet the expectation of the global change control board (if applicable) and meets site project timelines

- Participate in cross functional and cross site change management forums

- Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process

- Ensure completion of required change control actions prior to lifting lot disposition restrictions

- Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications

- Perform Change Records review in support of Annual Product Review activities

- Ensure maintenance and continuous improvement of change control and processes

- Support regulatory inspections and provide audit support with your team, which may include presentations and facility, utility, equipment documentation review

- Comply with Safety, Health & Environmental (SHE) requirements, mindful of safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable

- Observe all site security measures at all times, and report any suspicious characters/objects &
damaged security mechanisms to Site Security immediately

- Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

- Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent

- Familiar with Change Control Management Systems and stakeholders to involve

- Adherence to safety protocols and regulatory compliance

- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills

- Excellent communication skills, both written and verbal, in English