Total 3 transportation manufacturing production job vacancies in Quality Assurance / Control category in D09 Cairnhill, Orchard, River Valley

Job Responsibilities :

• Qualification/Validation Support:Assist in site projects related to qualification and validation.
  
• Document Review & Approval:Review and approve documents for Quality Control (e.g., Analytical Instrument Qualification, Method Validation, Critical Reagent Qualification).
  Ensure compliance with internal procedures and regulatory requirements.
  Evaluate and approve discrepancies in qualification/validation protocols and document corrective actions.
  
• Collaboration & Project Support:Act as Quality Representative for Quality Systems and Validation in projects.
  Provide validation expertise during development or modification phases of qualification activities.
  
• Quality Oversight:Ensure documentation of qualification/validation is clear and defendable during inspections.
  Provide oversight for Quality Control validation maintenance and Master Validation Plan.
  
• Multisite Coordination:Support harmonization of Quality Systems and validation activities across plants.
  
• Cross-Department Collaboration:Foster strong partnerships with other departments to ensure open communication.
  
• EHS & Conduct:Adhere to Environmental, Health, and Safety (EHS) requirements.
  Maintain behavior in accordance with Shire’s Code of Conduct.
  
• Other Duties:Perform any additional tasks as assigned by Manager/Supervisor.
  

Education and Experience Requirements:

• Education: Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or a related field. Additional certifications (e.g., Certified Quality Engineer, Validation topics) are a plus.
• Experience:2-3 years in pharmaceutical or biotechnology quality assurance, manufacturing, or validation (preferably in a multinational company).
  Hands-on experience with equipment, process, cleaning, computer systems, and shipping validation is an advantage.
  
• Regulatory Knowledge:Understanding of FDA/EU cGMP requirements (e.g., CFR 21 Part 11, PAT), ICH guidelines, and validation guides (e.g., PDA, ISPE GAMP).
  
• Problem-Solving & Communication:Ability to solve problems efficiently and interact diplomatically with diverse personalities.
  

Competencies:

• Study and understand Standard Operating Procedures (SOPs).
• Approve study, specification, and qualification/validation documents.
• Handle complex qualification/validation discrepancies.
• Assess internal procedures and external regulations
• Strong communication and organizational skills.

Requirements:

• Min Bachelor in any Science discipline
• Additional certificates such as Certified Quality Engineer would be advantageous
• Experience in biotechnology/pharmaceutical in QA/manufacturing operations preferred.
• Ability to work hands-on
• FDA/EU cGMP validation requirements and good understanding of ICH guidelines
• Critical thinking and problem solving skills

For interested candidates, please send your most recent and updated resume to temphc@recruitexpress.com.sg

WA me at http://wa.me/+6596698692

Alicia Cheong Ling Wei

R1104785

Recruit Express Pte Ltd

EA License No. 99C4599

Essential Functions

· The Quality Assurance Specialist is an adept technical writer/editor and the use of desktop Office applications.

· The QA Specialist must become familiar with site databases and proficient in the retrieval and presentation of information.

· The QA Specialist will trend this information using the graphical features of Microsoft Excel and display these in Microsoft Word reports. A major example is the Annual Product Review (APR).

· In addition the QA Specialist will lead in Change Control decisions and work with other departments to identify and solve issues that impact the product validation or the regulatory state.

· The QA Validation Specialist not only works with all site departments but supports Corporate Regulatory and R&D needs as well.

· The QA Specialist will support Regulatory Affairs with technical writing as pertaining to equipment and processes for product submissions and Request for Information (RFI).

· The QA Specialist will provide project support for the New Product launches and utilize Microsoft Project to organize site deliverables.

· Additional responsibilities may include assisting with validation activities associated with equipment and/or processes.

· The job may require travel to vendor sites to complete Factory Acceptance Testing in order to accept equipment for the site. Expect travel of less than 10%.

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately
• 
  

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Primary activities include, but are not limited to:

· Processing of customer complaints received against finished products including handling of returned customer complaint samples.

· Perform Adverse Event investigations and support compilation and analysis of PQC and AE data for Complaint Unit business processes.

· Support Market Action activities including BPDR/FAR submission, Fact Finding, and Recall

· Authoring Annual Product Reviews (APRs).

· Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site.

· Providing Quality oversight of supplier information across all categories of suppliers that service WP.

· Run queries / reports / metrics in support of business processes

· Update Standard Operating Procedures (SOPs) related to these business processes as needed.

· Participate/support compliance projects to sustain and/or enhance compliance

· Participate/support projects to enhance efficiency and effectiveness

· Support ad-hoc data requests and analysis

· Author, review, and approve procedures and other control documents.

· Assist with aspects of Regulatory Inspections and commitments

· Participate in internal audits and shop floor inspections

· Performing gap analysis and remediation

· Quality Support/ownership for applicable automation systems

· Regulatory surveillance

· Conduct training on compliance topics

· Execute projects as required by the Associate Director

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599