Total 4 job vacancies by Antaes Asia Pte. Ltd.

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
• Ensure compliance with regulatory standards and internal policies for all validation processes
• Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
• Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
• Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
• Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
• Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
• Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
• Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
• Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
• 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
• 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
• Experience with validation processes and quality oversight, including data integrity
• Strong understanding of cGMP regulations and validation principles
• Experience with risk assessment, gap analysis, and CAPA processes
• Problem-solving ability with a focus on proactive solutions and process improvement
• 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
• Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
• Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
• Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
• Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
• Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
• Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
• Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
• Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
• Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s degree in Biotechnology, Pharmaceutical or related field
• 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
• Experience with product and raw material release processes and related documentation
• Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
• Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
• Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
• Strong attention to detail and ability to work in a fast-paced, regulated environment
• Excellent communication and collaboration skills to work with cross-functional teams
• Good communication and problem-solving skills

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