QA Production Compliance Specialist

1 month ago

Singapore VENTAS BIO PTE. LTD. Full time
Roles & Responsibilities

Join Ventas Bio, a trailblazer in the realm of regenerative medicine. We are more than just a medical technology company. We are innovators dedicated to healing bodies through advanced science. Our team, driven by the "Think Biology" ethos, relentlessly pursues new paths in tissue and bone regeneration and wound healing.


At Ventas Bio, we're not just starting a project; we're continually setting new standards in the medical field. If you share our passion for pushing the boundaries of medicine, come aboard and contribute to shaping a healthier future.


Job Summary: We seek a QA Production Compliance Specialist with experience in lab-based production processes and a strong interest in QA/RA roles. This role is essential for ensuring our production operations meet the highest quality and regulatory standards.


Key Responsibilities:


Quality Assurance

  • Develop and implement quality assurance policies and procedures that comply with regulatory requirements, ensuring that all aspects of the production process are covered, from raw material reception to final product release.
  • Train staff on the latest QA/RA practices, updates, and regulatory changes, designing comprehensive training modules and conducting regular training sessions to enhance staff knowledge and compliance readiness.
  • Monitor and report on the effectiveness of QA/RA policies and interventions, utilising metrics and performance indicators to assess compliance levels, identify areas for improvement, and implement corrective actions as needed.
  • Coordinate with regulatory bodies for audits and ensure timely closure of findings by leading the preparation and follow-up actions, managing communications, and maintaining constructive relationships with inspectors and regulatory officials.
  • Perform risk assessments and root cause analyses on non-compliance issues or product defects, developing preventive measures to avoid future occurrences.
  • Review and validate the process, product labels, marketing materials, and packaging to ensure compliance with regulatory standards and that all information is accurate and legally compliant.
  • Participate in product development teams to provide regulatory guidance and ensure that new products are designed with compliance in mind from the outset.
  • Manage documentation and records according to legal and regulatory requirements, overseeing the creation, storage, and retrieval of all regulatory documents to ensure audit readiness.
  • Stay abreast of changes in regulatory legislation and guidelines, analyse implications forthe business, and adapt strategies and processes to maintain compliance.Production Process:
  • Collaborate with product process engineers to optimise and validate production processes.
  • Ensure production processes adhere to quality standards and regulatory requirements.
  • Implement quality controls and conduct routine inspections to minimise productiondeviations.
  • Facilitate the integration of quality standards into new and existing production lines.
  • Analyse production data to identify trends and areas for improvement in quality assurance.This document is the property of Ventas Bio Pte Ltd. It must not be reproduced in whole or in part or otherwise disclosed without prior written consent from Ventas Bio. All printed and electronic copies of versions except the one accessible on Ventas Bio’s server are considered uncontrolled copies used for reference only.

ERP Implementation

  • Assist in implementing and optimising an ERP system tailored to support production and regulatory needs.
  • Ensure the ERP system aligns with QA/RA requirements and facilitates efficient data management and reporting.
  • Coordinate training sessions for production and QA/RA teams on ERP functionalities.
  • Provide ongoing support and troubleshooting for ERP system issues.
  • Liaise between IT, production, and QA/RA departments to ensure the ERP system meets all user requirements.

Qualifications:

  • Proven lab-based production process experience with a strong focus on process validation.
  • Demonstrated interest and experience in QA/RA roles.
  • Bachelor’s degree in a relevant scientific or engineering field.
  • Excellent analytical, organisational, and communication skills.

Preferred Skills:

  • Previous experience in ERP system implementation within a production environment.
  • Familiarity with regulatory standards such as FDA, ISO and MDR etc.
  • Experience with audit management and compliance assessments.

Tell employers what skills you have

System Implementation
Quality Control
Supplier Quality
Labels
Quality Assurance
ERP
Data Management
ISO
Root Cause Analysis
Process Validation
Biology
Attention to Detail
Audit Management
Packaging
Quality Engineering
Audits
Regulatory Requirements
Process Control
Manufacturing
Audit

  • QA Specialist

    1 month ago

    Singapore PERSOLKELLY Singapore Full time

    Our client provides world-class distribution, technology, commercial, and integrated health solutions and services to support the growing healthcare needs.ResponsibilitiesCheck and approve repackaging requirements of products and materials according to Client and regulatory requirement. Full review of batch records to ensure compliance per the repackaging...

  • QA Specialist

    3 weeks ago

    Singapore PERSOLKELLY Singapore Full time

    Our client provides world-class distribution, technology, commercial, and integrated health solutions and services to support the growing healthcare needs.ResponsibilitiesCheck and approve repackaging requirements of products and materials according to Client and regulatory requirement. Full review of batch records to ensure compliance per the repackaging...

  • Quality Assurance

    3 weeks ago

    Singapore THE SUPREME HR ADVISORY PTE. LTD. Full time

    Roles & ResponsibilitiesQuality Assurance (QA) SpecialistWorking location: Jurong Island ( Transport pick up : Jurong East )Work hours: Monday to Friday (8 am to 4.30 pm)Salary range: $4500 - $5800Requirements: Diploma or Degree in relevant field Min 5 years’ experience in a petrochemical industryThe Quality Assurance (QA) Specialist is responsible for...

  • QA Specialist

    1 week ago

    Singapore RECRUIT EXPRESS PTE LTD Full time

    Roles & ResponsibilitiesQA Specialist (Pharma MNC) 6 months contractLocation: Tuas (Pickup available islandwide)Office hours, no shiftsMaintain and ensure site document management system, including procedures, guidelines, compliance to quality standards, regulatory requirementsEnsure documentations are updatedEnsure the control of changes /...

  • QA Specialist

    3 weeks ago

    Singapore PERSOLKELLY Singapore Full time

    Working Location: Changi NorthWorking Hours: 5 days, Mon - Fri, 8:30AM - 5:30PMContract Duration: 12 monthsJob Responsibilities: Check and approve repackaging requirements of products and materials Conduct full review of batch records to ensure compliance per the repackaging instruction and GMP standards.Perform required quality checks and create quality...

  • QA Specialist

    2 months ago

    Singapore PERSOLKELLY Singapore Full time

    Working Location: Changi NorthWorking Hours: 5 days, Mon - Fri, 8:30AM - 5:30PMContract Duration: 12 monthsJob Responsibilities: Check and approve repackaging requirements of products and materials Conduct full review of batch records to ensure compliance per the repackaging instruction and GMP standards.Perform required quality checks and create quality...

  • QA Specialist #HMST

    4 weeks ago

    Singapore Recruit Express Pte Ltd Full time

    Location: Tuas (Pickup available islandwide)Office hours, no shifts QA Specialist - 6 months contract Maintain and ensure site document management system, including procedures, guidelines, compliance to quality standards, regulatory requirements Ensure documentations are updated Ensure the control of changes / updates Distribution of effective documents to...

  • QA Specialist #HMST

    4 weeks ago

    Singapore Recruit Express Pte Ltd Full time

    Location: Tuas (Pickup available islandwide)Office hours, no shiftsQA Specialist - 6 months contractMaintain and ensure site document management system, including procedures, guidelines, compliance to quality standards, regulatory requirementsEnsure documentations are updatedEnsure the control of changes / updatesDistribution of effective documents to...

  • QA Specialist #HMST

    3 weeks ago

    Singapore Recruit Express Pte Ltd Full time

    Location: Tuas (Pickup available islandwide)Office hours, no shiftsQA Specialist - 6 months contractMaintain and ensure site document management system, including procedures, guidelines, compliance to quality standards, regulatory requirementsEnsure documentations are updatedEnsure the control of changes / updatesDistribution of effective documents to...

  • QA Specialist #HMST

    3 weeks ago

    Singapore Recruit Express Pte Ltd Full time

    Location: Tuas (Pickup available islandwide)Office hours, no shifts QA Specialist - 6 months contract Maintain and ensure site document management system, including procedures, guidelines, compliance to quality standards, regulatory requirements Ensure documentations are updated Ensure the control of changes / updates Distribution of effective documents to...

  • QA & Testing, Fx Specialist

    1 week ago

    Singapore Danos Group Full time

    Danos GroupSingaporePosted 24 hours ago Hybrid Permanent S$125k - S$150k POSTED BY Michael Bishop Head of Cyber Risk, APACFollow This role is an exciting opportunity for a QA functional specialist with FM eTrading and FX experience to be part of a large multiasset eCommerce trading system development & QA team that is distributed over London, Singapore, and...

  • Quality Assurance

    3 weeks ago

    Singapore THE SUPREME HR ADVISORY PTE. LTD. Full time

    Roles & ResponsibilitiesQuality Assurance (QA) SpecialistWorking location: Jurong Island ( Transport pick up : Jurong East )Work hours: 8 am to 4.30 pm (Mon to Fri)Salary range: $4500 - $5800The Quality Assurance (QA) Specialist is responsible for the development, implementation and promotion of QA related activities and compliance in the company. He/ She is...

  • QA Supervisor

    1 week ago

    Singapore BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD. Full time

    Our client is a pharmaceutical giant with a global presence, with expansion plans in Singapore.Roles and Responsibilities Lead and supervise QA Specialists developing their QA skillset Review and approve working procedures for QA Manufacturing Plan and create SOPs, scheduling relating to manufacturing and laboratory investigations Conduct training on...

  • Quality Assurance

    3 weeks ago

    Singapore PRIMESTAFF MANAGEMENT SERVICES PTE LTD Full time

    Roles & ResponsibilitiesThe Quality Assurance (QA) Specialist is responsible for the development, implementation and promotion of QA related activities and compliance in the company. He/ She is also responsible to: Establish, implement, maintain & improve the management systems, namely: ISO 9001, ISO 14001, SS 651 Establish, implement, review & improve on...

  • Quality Assurance

    1 month ago

    Singapore PRIMESTAFF MANAGEMENT SERVICES PTE LTD Full time

    Roles & ResponsibilitiesThe Quality Assurance (QA) Specialist is responsible for the development, implementation and promotion of QA related activities and compliance in the company. He/ She is also responsible to: Establish, implement, maintain & improve the management systems, namely: ISO 9001, ISO 14001, SS 651 Establish, implement, review & improve on...

  • QA Specialist

    1 month ago

    Singapore Danaher Corporation Full time

    Be part of something altogether life-changing Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • QA Specialist

    1 month ago

    Singapore GLOBAL LIFE SCIENCES SOLUTIONS SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesBe part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At...

  • QA Specialist

    1 week ago

    Singapore Danaher Corporation Full time

    Be part of something altogether life-changing Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • QA Specialist

    3 weeks ago

    Singapore Danaher Corporation Full time

    Be part of something altogether life-changing Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • QA Specialist

    1 week ago

    Singapore GLOBAL LIFE SCIENCES SOLUTIONS SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesBe part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva...