Total 18 it specialist job vacancies in Quality Assurance / Control category in d09 cairnhill orchard river valley

RESPONSIBILITIES

• Project Management: Analytical, Raw Material and Microbiological Method Introduction
• Project Management: Analytical Equipment Qualification
• Regulatory Filing and Method launches
• Invalid results tracking, trending and investigation
• Unexpected results investigation
• Control Trend establishment and investigations
• Reference Standard and Reagent qualifications
• Compendia review
• Continuous Improvement
• Audit Preparation and Involvement and other tasks as assigned

REQUIREMENT

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

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

• Perform review and release of materials, including therapeutic products intended for clinical trials and packaging components.
• Provide support on Quality matters to Project Management / Operations in the area of clinical packaging, storage and distribution.
• Evaluate effectiveness and identify process improvements.
• Review and approval of Change Control, Complaints, and Deviation reports.
• Monitor closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations.
• Manage site SOP System, including review, update and approval of SOPs.
• Approve specifications, sampling instructions and other Quality Control procedures.
• Review and approval of validation/qualification documents.
• Perform the role of a System Administrator for Quality-related Computerized Systems.

PM me NOW @jesswongie OR whatsapp 96503173

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

Jessie Wong Yuan Si

Personnel EA License No.: R2197171

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

The Opportunity

• Opportunity to work with MNC Client
• 5 days' work week, Office Hours
• Working location: CBD

Key Responsibilities:

1. EN 9100 Certification Preparation:
   • Lead the deployment and implementation of EN 9100 standards within the new factory.
   • Develop and oversee the creation of required process documents, including Quality Manuals, flowcharts, procedures, and work instructions.
2. Process Optimization and Documentation:
   • Conduct process mapping to define and document process flows, interfaces, inputs/outputs, criteria, and KPIs.
   • Establish and maintain dashboards to monitor quality performance and ensure compliance with EN 9100 standards.
3. Auditing and Compliance:
   • Conduct internal and external audits in line with certification requirements (e.g., EN 9100, ISO 9001, ISO 14001, etc.).
   • Support and coordinate Management System Certification audits, ensuring successful outcomes.
4. Team Engagement and Communication:
   • Act as the primary point of contact for all quality-related activities, engaging with cross-functional teams to align actions with certification goals.
   • Drive team collaboration through effective communication, synthesizing information, pushing action plans, and ensuring feedback loops.
5. Continuous Improvement:
   • Identify gaps and areas for improvement within existing processes and implement corrective actions.

Required Qualifications and Skills:

Education and Experience:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 3 years of experience in EN 9100or ISO 9001 standard deployment or operations.

Technical Skills:

• In-depth knowledge of EN 9100 standards (ISO 9001 knowledge is acceptable if complemented by relevant experience).
• Proven expertise in internal and external audits, with experience in certifications such as ISO 9001, EN 9100, ISO 14001, or ISO 17025.
• Strong process-oriented mindset with the ability to map processes, define KPIs, and develop dashboards.
• Proficient in creating and revising quality documentation, including manuals, flowcharts, and procedural instructions.

Next Step

Prepare your updated resume and expected package.

Simply click on 'Apply here' or email to [email protected] to drop your resume

All shortlisted candidates will be contacted.

Prasant Sirohi

EA Licence Number: 91C2918

Registration Number: R22106307

Responsbilities

• Review and analyze system specifications and requirements.
• Develop and document detailed test plans, test cases, and test scripts.
• Perform manual testing on web, mobile, and desktop applications to identify defects and areas of improvement.
• Execute different types of testing including functional, integration, system, regression, smoke, sanity, and exploratory testing.
• Validate user interfaces (UI), workflows, and overall usability. Identify, document, and track defects using bug-tracking tools (e.g., JIRA, Bugzilla, Zephyr,etc.)
• Work closely with developers to reproduce bugs, provide steps to reproduce, and verify fixes.
• Collaborate with developers, product owners, and designers to ensure proper test coverage and seamless product delivery.
• Provide feedback on product design and feature improvements from a user perspective.
• Participate in team meetings and contribute to discussions on product quality and improvement.
• Prepare test data for different test scenarios and ensure consistency throughout testing phases.
• Verify and validate data integrity in database testing.
• Any other ad-hoc duties as assigned by supervisor.

Requirements

• Bachelor’s degree in computer science, Information Technology, Engineering, or a related field (or equivalent practical experience).
• 3+ years of experience in manual testing.
• Familiarity with different testing methodologies (Agile, Waterfall, etc.).
• Hands-on experience with testing web, mobile, and/or desktop applications.
• Knowledge of SQL queries for backend/database testing.
• Strong understanding of software development lifecycle (SDLC) and testing lifecycle (STLC).
• Proficiency in writing clear, concise, and comprehensive test cases.
• Experience with bug tracking systems (e.g., JIRA, Redmine, etc.).
• Knowledge of automated testing tools and frameworks (though this is a manual tester role, familiarity with automation is a plus).
• Experience with API testing using tools like Postman.
• Understanding of performance and load testing concepts.
• Experience in working with CI/CD pipelines.

Interested applicants, please email your resume to Andre Chua Jing Ming

Email: [email protected]

CEI Reg No: R1989053

EA Licence No: 99C4599

Recruit Express Pte Ltd

Job Responsibilities:

• Support daily Quality Assurance activities, ensuring compliance with approved SOPs and policies in a multi-product, contract manufacturing facility.
• Provide quality oversight (participate GEMBA walk, GMP walk)
• Apply a solid understanding of cGxPs in a GxP setting, performing tasks with minimal supervision.
• Revise, review, and approve SOPs, protocols, reports, and records to ensure accuracy and compliance.
• Make real-time decisions on process events based on knowledge of SOPs and policies.
• Promote collaboration within teams to achieve objectives, demonstrating strong interpersonal skills.
• Perform other tasks as assigned by the supervisor to support the Quality Assurance department.
• Perform IQ and OQ. Involve in URS, design specifications

Requirements:

• Min Diploma/Degree in science related
• Knowledge of regulatory requirements and GMP quality systems.
• Experience in Quality Assurance in any industry

Interested candidates, do submit your resume to [email protected]

Attn: Ariel Fong Jea Yee (Outsourcing Team)
Audrey Chan Yu Jing (R1104782)

Recruit Express Pte Ltd (99C4599)

EA License No: 99C4599

EA Personnel No: R1761665

Job Scope

• Project management: analytical, raw material and microbiological method introduction and analytical equipment qualification
• Assist in regulatory filing and method launch
• Helping out in invalid results tracking, trending and investigation
• Conducting unexpected results investigation
• Control trend establishment and investigations
• Reference standard and reagent qualifications
• Conducting compendia review
• Assisting in audit preparation and involvement and other tasks as assigned.

Job Requirements

• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Six Sigma Greenbelt training would be helpful.
• Demonstrated experience e.g. in the area of method validation, method transfer, method verification.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

For interested candidates, please send your updated resume:

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Quality Standards (QS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

For interested candidates, please send your updated resume:

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

R2197171

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, including CFR 21 Part 11, 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.

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

Apply now!

Job Scope

• Project management: analytical, raw material and microbiological method introduction and analytical equipment qualification
• Assist in regulatory filing and method launch
• Helping out in invalid results tracking, trending and investigation
• Conducting unexpected results investigation
• Control trend establishment and investigations
• Reference standard and reagent qualifications
• Conducting compendia review
• Assisting in audit preparation and involvement and other tasks as assigned.

Job Requirements

• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Six Sigma Greenbelt training would be helpful.
• Demonstrated experience e.g. in the area of method validation, method transfer, method verification.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

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.

Location: Kranji (Near MRT, 5-minute shuttle bus)
Contract Duration: 6 months (with potential extension)

Key Responsibilities:

• Revise and review Standard Operating Procedures (SOPs)
• Review executed Master Batch Records (MBR) and Electronic Batch Records (EBR)
• Provide quality support and interpretation to the manufacturing team on quality-related queries and issues
• Participate in GEMBA and GMP walks for quality oversight
• Archive Quality Operations (QO) documents and support IQ/OQ activities
• Contribute to User Requirement Specifications (URS) and design specifications

Primary Job Objectives:

• Support the implementation and maintenance of quality systems
• Provide quality oversight for validation-related activities, including data integrity
• Ensure compliance with internal procedures and regulatory requirements, including FDA/EU cGMP and ICH guidelines

Requirements:

• Minimum of 2-3 years of experience in pharmaceutical/biotechnology quality assurance, manufacturing, or validation (preferably in multinational companies)
• A degree in pharmaceutical sciences, life sciences, biotechnology, chemistry, chemical engineering, or related fields. Certification in Quality Engineering or Validation topics is a plus
• Hands-on experience with equipment, process, cleaning, computer systems & shipping validation is advantageous
• Knowledge of FDA/EU cGMP, CFR 21 Part 11, and ICH guidelines is essential
• Strong problem-solving skills and ability to interact effectively with cross-functional teams
• Excellent verbal and written communication skills

All qualified applicants, please click “ APPLY NOW”

Or you may send in your resume to:

Whatsapp: https://wa.me/+6597430026

Email : [email protected]

Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122

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

Description:

The role will assist the Compliance team to oversee and manage regulatory compliance projects within our organization, working closely with the Head of Regulatory Liaison, Conduct and Culture, Chief Compliance Officer, wider Compliance team and key business stakeholders. The successful candidate should have a keen eye for detail, excellent project management skills, and a deep understanding of regulatory compliance.

Key Responsibilities:
• Support, plan, execute, and manage regulatory compliance projects from inception to completion, ensuring adherence to timelines, and quality standards.
• Provide regulatory compliance advisory to management and business stakeholders.
• Maintain comprehensive project documentation, including project plans, status reports, risk assessments, and compliance records.
• Serve as the primary point of contact for regulatory compliance projects, providing regular updates to core project team and business stakeholders.
• Deep understanding of regulations and industry standards.
• Ability to understand and interpret complex regulatory legislation.
• Works well independently and a strong team player.

Qualifications:
• Minimum of 5 to 10 years of regulatory compliance experience.
• Experience in insurance industry, with proficiency in Insurance Act, Financial Advisers Act and industry requirements is preferred.
• Strong analytical and problem-solving abilities, with excellent project management skills.
• Good communication and interpersonal skills.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently and as part of a team.
• Proficiency in project management methodologies and software, and Microsoft Office Suite.

Must-have criteria:

· 3-5 years of compliance regulatory experience, preferably from insurance

· Familiar with Financial Advisers Act 2001, Insurance Act 1966 and subsidiary regulations

· Being able to advise, communicate and manage different business stakeholders

To apply, please email your resume in MS Word format to [email protected] indicating in your CV the following information:

Expected Salary:
Notice Required:
Reason for Leaving:

Only shortlisted candidates will be notified.

Jackie Ng May Ying (R1104602)

Recruit Express Pte Ltd

EA No: 99C4599

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

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

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

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 [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 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 l[email protected]

Thank You.

Leon Leong De Cong
R1551708

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

Job Scope:

• Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Improve quality assurance systems, as necessary.
• Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
• Conduct internal audits to ensure the internal controls are effective.
• Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
• Maintain inspection readiness and suppmt 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
• Qualify and manage suppliers according to Quality Standards (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk.
• Ensure supplier and material is qualified timeline to support production schedule.

Requirement:

• Bachelor Degree / Diploma in Science/Chemical Engineering or equivalent

If you are interested in exploring this role or other current openings in the market, kindly email me at [email protected] with your resume.

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

Jobscope

• 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.
• Develop and maintain document control process for efficient management and record all documentation
• Ensure proper document classification, sorting, filing and proper archiving
• Performs document quality check in accordance to company ISO document control procedures.
• Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date.
• Undertake various functions related to document control, document archiving, document imaging and maintenance of document register
• Provide administrative support on the area of drafting document control and documentation.

Requirements

• Diploma/ Degree in Biological Science or any related Engineering
• Quality Assurance experience is advantageous
• Pharmaceutical GMP / Lifescience environment will be highly preferred

Apply now by sending your resume to [email protected] for more enquiries.

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

Tammy Yap | Outsourcing Team | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W