Total 113 quality assurance job vacancies in Singapore

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 1-3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to:
[email protected]

Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Responsibilities

• Support the site projects on Qualification/ Validation
• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.
• Provide validation expertise, oversight and support for the development (or modification phases) of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.
• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.
• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.
• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.
• Build strong partnership with all other departments to ensure open communications and acceptance
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
• Any other duties as assigned by Manager/ Supervisor.

Education and Experience Requirements

• The candidate should have at least have a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline. Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• A minimum experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation, ideally in a multinational company. Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages.
• FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
• Able to logically solve problems in order to find timely solutions.
• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.

Apply now by sending your resume to: [email protected]

We regret to inform that only shortlisted candidates will be notified.

Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

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 [email protected]

Thank You.

Leon Leong De Cong
R1551708

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

Quality Assurance Manager

Key Responsibilities
• Serve as the main Quality point of contact related to suppliers
• Manage External site to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements
• Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
• Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
• Provide quality oversight of the manufacturing, testing, and release of materials at External site
• Author and drive actionable site inspection readiness plans
• Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
• Representation at product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
• Identify and mitigate risk at the External site
• Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
• Escalate risks or roadblocks to management
• Drive timely decision making using principles
• Drive continuous improvements

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• Min 5 years relevant experience in a related industry preferred
• Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA/ QO)

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Quality Assurance Engineer

· Perform Quality Assurance/Quality Engineering to ensure components, finished products and processes meet established specifications.

· Analyse material and processes and make recommendations/ take action to correct deficiencies.

· Troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems.

· Disposition non-conforming material requiring advanced process/technical knowledge. Work directly with suppliers to prevent or correct discrepant material

· Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts).

· Implement corrective and preventative actions.

· Work with Production, Manufacturing/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes.

· Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally

· Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.

· Develop and review documented operating procedures associated with material inspection or processes

Our requirements:

• Min Diploma or Degree in Biomedical Engineering
• Min of 2 years’ experience in QA Biomedical Engineering
• Must possess excellent team work and interpersonal skills with a strong emphasis on good analytical skills
• Possess good customer interactions skills
• Sound ability to troubleshoot and repair
• Good communication skills

If you are interested in the position, do kindly drop your most updated resume to [email protected] (Attn: QA Engineer)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

• Assist in the development, management, and implementation of the SingEdExcel framework across schools.
• Support the Vice President in monitoring, reviewing, and evaluating the effectiveness of the framework and the knowledge repository.
• Maintain documentation of all policies and procedures, ensuring they are up-to-date and accessible in the knowledge repository.
• Assist in organising professional learning sessions for school leaders on the SingEdExcel framework and SMM Knowledge Repository.
• Coordinate and manage documentation and evidence gathering for the EduTrust certification renewal exercise.
• Assist in the development and implementation of data protection policies and procedures.
• Support in conducting data protection risk assessments and audits across all schools.
• Monitor compliance with data protection laws and regulations and report findings to the Group DPO.
• Coordinate data protection training and awareness programmes for staff.
• Maintain comprehensive records of data processing activities and assist in the preparation of reports on data protection compliance.
• Other adhoc duties as assigned

Job Specification

• Recognised bachelor’s degree in Education, Business Administration, Quality Management, or a related field.
• Minimum of 3 years of experience in quality assurance, compliance management, or a related field.

Joy Yeow Zhi Qian

(CEI Registration No:R2096261)

Recruit Express Pte Ltd (EA Licence No: 99C4599)

Job Description

• Responsible to review and approve the Quality Control related protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.

• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.

• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.

• Provide validation expertise, oversight and support for the development of Analytical Instrument Qualification and Microbiology Method Validation

• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.

• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.

• Build strong partnership with all other departments to ensure open communications and acceptance

Requirements

• Min Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline

• A minimum experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations will be preferred

Interested candidates are invited to email your resume to:

[email protected]

Jenalyn Ooi Huai Sian (R1765551)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

We regret only suitable candidates will be shortlisted for an interview.

Responsibilities (include but are not limited to):

• Work with the Manufacturing department as a production area Quality Assurance representative

• Coordinate and facilitate Quality Assurance related production and production related activities

• Ensure timely issuance of production records, procedures and labels

• Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

• Review batch-related documentation, and ensure resolution of issues to release product

• Communicate lot disposition pending issues to Management

• Ensure approval and timely delivery of Final Product

• Ensure that products are manufactured in compliance with regulatory and GMP guidelines

• Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

• Review and approve Manufacturing Production Records

• Compile and verify all batch related documents into a Final Product lot disposition package

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

• Review and disposition disposable raw materials and components for GMP use

• Review equipment and facility technical and investigation reports

• Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

• Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

• Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents

• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

1. Quality Assurance Specialist Job Description

Reporting to QA Supervisor

Objective of Role

• This position is part of the Quality Assurance team responsible for implementation and maintenance of the various Quality Systems and release of incoming material to achieve the site objectives for the company.

• To build up a pipeline of skilled manpower for Singapore’s biologics manufacturing industry

General responsibilities:

• Participating in investigations relating to laboratories/ incoming material release/ systems and review the

investigation report.

• Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to

ensure compliance with DM/DPs revision, where gaps are identified, ensure that an

implementation/mitigation plan is in place and follow-through to completion.

• Support the compliance, audit, regulatory and training activities as required and any other responsibilities

as assigned by Supervisor

• Leadership

o Build strong partnership with all other departments to ensure open communications and acceptance o Commitment to a fair and respectful relationship to others and behavior in accordance with the company.

Code of Conduct

• EHS

o Responsibility to adhere to any applicable EHS requirements

• Any other duties as assigned by supervisor.

Other responsibilities:

• Quality System(s) implementation and maintenance (if assigned)

o Participate in Quality System(s) rollout by ensuring that the following elements of the Quality System(s) are implemented and maintained at the site according to regulatory, corporate and division requirements:

o Nonconformance/CAPA, Change control, Incoming Release, Quality Management Review, Customer complaints, Annual Product Review/Product Quality Review, Product Recall

o Responsible for the development and writing of Quality systems and QA related procedures • Perform assessments and tasks related to change controls pertaining to Quality System

o Raw Material release (if assigned)

o Responsible for the development and writing of incoming material specifications.

o Ensure timely release of incoming material

o Perform assessments and tasks related to change controls pertaining to incoming release (if assigned)

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• Min 5 years relevant experience in a related industry preferred
• Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA/ QO)

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

We are hiring Quality Specialist to be outsourced to our clients from reputable healthcare organizations.

Apply now!

Job Scope

· Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with company procedures and regulations.

· Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.

· Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.

· Act as Quality Representative: Participate in cross-functional projects as the Quality Systems and Validation representative.

· Provide Validation Expertise: Offer guidance on creating or updating validation documents, such as for analytical instruments and methods.

· Ensure Document Readiness: Ensure all qualification/validation documents are clear and inspection-ready.

· Support Ongoing Validation: Oversee the Master Validation Plan and support routine qualification activities.

· Collaborate Across Sites: Help standardize validation processes across multiple sites.

· Train and Coach: Develop training materials and provide support to team members and other departments.

Job Requirements

· Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, Engineering, or related field.

· At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry. Experience in equipment, process, cleaning, and computer systems validation is preferred.

· Strong understanding of FDA/EU cGMP requirements and familiarity with PDA and ISPE GAMP guidelines.

All Interested candidates are invited to email your resume in MS Word format to:

[email protected]

Please include your full working experience, education background, notice period, expected salary.

Sheryl Tan

Outsourcing Team
Recruit Express Pte Ltd
Company Reg. No. 199601303W | EA License Number: 99C4599

We regret to inform that only suitable candidates will be shortlisted for an interview.

Duration: 6 months

Salary: $4500 - 8000 (Depending on experience)

Working Hours: 5 days office hours

Job Scope:

• Support the site projects on Qualification/ Validation

Assessment and Approval of Documents

• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.

• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.

• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.

• Provide validation expertise, oversight and support for the development (or modification phases) of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.

• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.

• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.

• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.

• Build strong partnership with all other departments to ensure open communications and acceptance

• Responsibility to adhere to any applicable EHS requirements.

• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

• Any other duties as assigned by Manager/ Supervisor.

Job Requirements:

• Min. Degree in any relevant science field preferably in pharmaceutical or life sciences
• Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• Min. 2-3 years relevant experience in pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation.
• Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages.FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.

For interested applicants, please send your updated resume to: [email protected]

All candidates’ information will be treated with the strictest confidence

Melissa Zhang Zhiqi (Mezzo)

R2197564

Recruit Express Pte Ltd

99C4599

Location: Chinatown

Woirking hours: 8.30am to 5.30pm (Mon-Fri)

Job Scope

• Assist in the development, management, and implementation of the framework across schools.
• Support the Vice President in monitoring, reviewing, and evaluating the effectiveness of the framework and the knowledge repository.
• Coordinate with school leaders and staff to ensure effective adoption and implementation of standardised policies and procedures.
• Maintain documentation of all policies and procedures, ensuring they are up-to-date and accessible in the knowledge repository.
• Support the Vice President in serving as an internal assessor for schools preparing for EduTrust certification.
• Assist in reviewing EduTrust-related documents.
• Assist in the development and implementation of data protection policies and procedures.
• Support in conducting data protection risk assessments and audits across all schools.
• Coordinate data protection training and awareness programmes for staff.
• Other ad hoc duties assigned

Job Requirements

• Bachelor’s degree in Education, Business Administration, Quality Management, or a related field.

• Minimum of 3 years of experience in quality assurance, compliance management, or a related field.

• Minimum of 1 year of experience with data protection and privacy laws, and their implementation in organisational processes.

• Knowledge of quality/compliance management systems and frameworks (e.g., EduTrust, ISO 21001) is essential.

• Any additional certifications in quality management or project management will be beneficial.

Interested applicants please send your resumes to [email protected]

Jessica Nguyen Huynh Thanh Truc

Recruiter (R23113787)

EA License No. 99C4599

We regret that only shortlisted candidates will be notified.

1. Revise and review SOPs
2. Review executed MBR/EBR
3. Support manufacturing team with any quality interpretation , queries and issues.
4. Provide quality oversight (participate GEMBA walk, GMP walk)
5. Perform archival of QO documents
6. Perform IQ and OQ. Involve in URS, design specifications

Interested applicants please email a copy of your resume to [email protected]

Tele @jesswongie OR WA 96503173

Jessie Wong Yuan Si

Personnel EA License No.: R2197171

Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Quality Assurance / Quality Specialist / Quality Engineer

Company Overview

Location: Kranji (near MRT with a 5-minute shuttle bus)

Number of Openings: 9
Duration: 6-month
Salary: up to 8K

Job Responsibilities:

1. Documentation and Quality Oversight:Revise, review, and approve SOPs, MBR/EBR, and QO documents.
   Provide quality guidance and support to the manufacturing team, addressing quality queries and issues.
   
2. GMP and Compliance:Conduct quality oversight activities, including GEMBA and GMP walks.
   Adhere to and enforce cGMP and regulatory requirements, especially for FDA and EU compliance.
   
3. Qualification/Validation Support:Perform IQ/OQ tasks and assist in validation activities including Data Integrity, Analytical Instrument Qualification, Analytical and Microbiology Method Validation, and Critical Reagent Qualification.
   Review and approve related protocols, reports, and ensure alignment with regulatory requirements.
   
4. Project Involvement and Collaboration:Act as the Quality Representative in cross-functional projects.
   Provide validation expertise and maintain Master Validation Plans.
   Collaborate on multi-site initiatives to harmonize Quality Systems across plants.
   
5. Documentation Integrity and Inspection Readiness:Ensure documents are clear, compliant, and defendable during audits.
   Support multisite initiatives to align validation activities across locations.
   
6. Other Responsibilities:Build and maintain partnerships with internal departments.
   Adhere to EHS requirements and Shire’s Code of Conduct.
   

How to Apply: Send your resume to Jocelyn Chan at [email protected] or contact via Telegram @jocelynchan.

Jocelyn Chan | Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience) Company EA Licence Number: 99C4599 Personnel EA License: R1331820

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 1-3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to:

[email protected]

Tricia Celestine Goh (R1981653)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

1. Revise and review SOPs
2. Review executed MBR/EBR
3. Support manufacturing team with any quality interpretation , queries and issues.
4. Provide quality oversight (participate GEMBA walk, GMP walk)
5. Perform archival of QO documents
6. Perform IQ and OQ. Involve in URS, design specifications

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

Personnel EA License No.: R2197171

Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Job Responsibilities:

• Report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
• Assist in the development of action plans and implementation schedules, and the verification of completed actions.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
• Conduct and report the findings of internal investigations of compliance issues.

Job Requirements:

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant biopharmaceutical/ pharmaceutical experience.
• Minimum 2 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to:

[email protected]

Tricia Celestine Goh (R1981653)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

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 [email protected]

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

Alicia Cheong Ling Wei

R1104785

Recruit Express Pte Ltd

EA License No. 99C4599

Responsibilities:

• Perform all aspects of QC responsibilities as it pertains to release activities that will include but is not limited to: sampling, testing, and disposition of raw materials and final packaging/ component lots
• Support additional areas of QC including Rejected, Quality Hold, and Non-conforming materials.
• Perform all activities adhering to strict cGMP guidelines
• Maintain on-time completion of all training requirements
• Perform simple laboratory instrument up keep including the cleaning, calibration, and the preventative maintenance of the instrument as outlined within the departments governing procedures
• Participate in department initiatives to support the continuous improvement of the quality systems of the QC department
• Practice safe work habits and adhere to safety procedures and guidelines

Requirements:

• Min Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical / chemical industry.
• Experience in operating laboratory equipment such as HPLC, GC , KF Titrators.
• Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
• 5 days office hours

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Location: Jurong Pier (Transport pickup from Lakeside)

Salary Rage: Up to S$4,000 + AWS + VB

Working hours : 8.15am – 5.30pm (Mon-Thurs)/ 8.15am – 5pm (Fri)

Responsibilities:

• Support in the maintenance of Safety, Quality, Environmental, and Health Management Systems such as ISO 9001, ISO 14001, ISO 45001
• Support in the implementation of IATF 16949 quality standards.
• Ensure IATF core tools are effectively established in quality assurance process in compliance with IATF 16949 standards.
• Analysis of quality data to identify potential systemic issues & initiate improvements.
• Conduct internal audits, identify non-conformances, and lead corrective actions to ensure ongoing compliance with ISO and IATF standards.
• Other ad hoc duties assigned.

Experience & qualification

• Diploma or Degree in Manufacturing/Mechanical Engineering/Quality or equivalent
• Minimum 3-4 years relevant experience
• Proven experience in Quality Assurance (preferably in manufacturing environment).
• Strong knowledge and ability to apply core tools under IATF 16949 requirements.

Interested applicants please send your resumes to [email protected]

Jessica Nguyen Huynh Thanh Truc

Recruiter (R23113787)

EA License No. 99C4599

We regret that only shortlisted candidates will be notified.

Job Responsibilities:

• Report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
• Assist in the development of action plans and implementation schedules, and the verification of completed actions.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
• Conduct and report the findings of internal investigations of compliance issues.

Job Requirements:

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Tuas

Monday to Friday office hour

12 months

up to 5K

• GMP systems knowledge with Supplier Quality Management concept
• Will require the personnel to reach out to supplier or support the senior supplier qual specialist to support documentation compilation and GMP/GDP review per procedural requirements
• Knowledge of GDP and DMS (documentation management systems) general knowledge to support doc center activities if required
• Looking for enthusiastic people that are interested and committed to support Quality systems processes and potential participation in new product introduction activities

Interested candidates, do submit your reusme to: [email protected]
Telegram me at @jocelynchan

Jocelyn Chan
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820
[email protected]'

Salary: up to $8000

Duration: 6 months contract

Working Days & Hours: Mon-Fri Office Hours

Location: Kranji

Job Description:

• Partner with the Subject Matter Expert, assist the validation team with gap analysis/risk assessment prior to qualification activities, and where gaps are identified, proposed mitigation plans.

• Participate in validation discrepancy investigations, assist in the review & approval of the discrepancy reports and support associated CAPA closures.

• Review and approve validation documents not limited to protocols and reports.

• Provide support with any validation queries and issues.

• Review and approve routine SOPs, FORMs and any relevant procedures including Manufacturing Batch Records

• Product / Raw Material Release skillset (Review and Release)

• Quality oversight for manufacturing

• GEMBA walk / GMP walk-through

• Revise, review and approval of procedures (SOPs, forms, Manufacturing Batch Records)

Job Requirements: Min Degree in Life Sciences or similar w min 5 yrs of relevant experience in GMP/Pharma

Interested candidates, please submit your resume to: [email protected]

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

[email protected]

Location: Jurong Pier (Transport pickup from Lakeside)

Salary Rage: Up to S$4,000 + AWS + VB

Working hours : 8.15am – 5.30pm (Mon-Thurs)/ 8.15am – 5pm (Fri)

Responsibilities:

• Support in the maintenance of Safety, Quality, Environmental, and Health Management Systems such as ISO 9001, ISO 14001, ISO 45001
• Support in the implementation of IATF 16949 quality standards.
• Ensure IATF core tools are effectively established in quality assurance process in compliance with IATF 16949 standards.
• Analysis of quality data to identify potential systemic issues & initiate improvements.
• Conduct internal audits, identify non-conformances, and lead corrective actions to ensure ongoing compliance with ISO and IATF standards.
• Other ad hoc duties assigned.

Experience & qualification

• Diploma or Degree in Manufacturing/Mechanical Engineering/Quality or equivalent
• Minimum 3-4 years relevant experience
• Proven experience in Quality Assurance (preferably in manufacturing environment).
• Strong knowledge and ability to apply core tools under IATF 16949 requirements.

Interested applicants please send your resumes to [email protected]

Jessica Nguyen Huynh Thanh Truc

Recruiter (R23113787)

EA License No. 99C4599

We regret that only shortlisted candidates will be notified.