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IPQA Project Engineer - Job Opportunity at COMBUILDER PTE LTD

Singapore, SG
Contract
Mid-level
Posted: July 19, 2025
On-site
SGD 5,000 - 6,000 per month

Key Responsibilities

Drive cross-functional collaboration between IT and QA teams to optimize incident management processes, ensuring rapid resolution and continuous improvement in quality systems performance
Lead digital transformation initiatives in quality assurance by managing sophisticated electronic batch record systems and real-time data platforms, directly impacting production efficiency and compliance
Oversee critical Master Batch Record configuration and version control within digital quality management systems, ensuring seamless operations and regulatory compliance across all manufacturing processes
Establish robust data integrity frameworks through validation of data flows and metadata management, creating comprehensive audit trails that protect the organization from regulatory risks
Architect and manage enterprise-level quality workflow systems, coordinating deviation management, out-of-specification investigations, and change control processes that directly impact product quality and market readiness
Champion system optimization initiatives by leading quality module enhancements based on audit findings and evolving regulatory landscapes, positioning the organization ahead of compliance requirements
Transform raw quality data into strategic insights through advanced statistical analysis and visualization, creating comprehensive Annual Product Quality Review reports that inform executive decision-making
Ensure organizational audit readiness by maintaining ALCOA+ compliant digital quality records, safeguarding the company's regulatory standing and market access
Support high-stakes regulatory audits through structured data management and document control systems, protecting company reputation and market authorization
Implement comprehensive data governance frameworks ensuring compliance with international regulatory standards including 21 CFR Part 11 and EU Annex 11, maintaining global market access
Lead IT-quality integration projects managing user access controls, electronic signatures, and system security protocols that protect sensitive manufacturing and quality data
Drive operational excellence through Lean IT and Six Sigma methodologies, delivering measurable improvements in reporting efficiency, process turnaround times, and documentation accuracy
Evaluate and implement cutting-edge automation solutions that enhance QA performance and compliance capabilities, positioning the organization for future regulatory challenges

Requirements

Education

Bachelor's Degree in Engineering, Information Technology or related field of studies

Experience

At least 5 years' experience with product lifecycle quality processes in a digitally enabled QA environment

Required Skills

strong understanding of data integrity Computerized Systems Validation (CSV) eQMS Platforms: TrackWise, SAP QIM, MasterControl eBMR Tools such as BizApp, LMS integration Data Analysis like JMP, Minitab and SPSS Regulatory Frameworks 21 CFR Part 11, EU Annex 11, ICH Q7–Q10, PIC/S Validation & Compliance: ALCOA+, GAMP5, Audit Trail Reviews, CSV Principles

Certifications

Preferred certifications - Certified Six Sigma Green Belt and Certified Quality Auditor
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and biotechnology industries are experiencing unprecedented digital transformation, with companies investing heavily in electronic quality management systems and real-time manufacturing data platforms. This shift is driven by regulatory pressures for enhanced data integrity and the need for more agile, responsive quality operations. Organizations are moving away from paper-based systems toward fully integrated digital ecosystems that can provide real-time visibility into quality metrics and enable predictive analytics for quality risk management. Regulatory authorities globally are intensifying their focus on data integrity and computerized system validation, with recent guidance documents from FDA and EMA emphasizing the critical importance of ALCOA+ principles and robust audit trails. This regulatory evolution is creating high demand for professionals who can navigate complex compliance requirements while implementing sophisticated technology solutions that enhance rather than complicate quality operations. The integration of artificial intelligence and machine learning into quality management systems is becoming mainstream, with companies seeking professionals who can bridge the gap between traditional quality assurance practices and emerging digital technologies. This trend is particularly pronounced in Asia-Pacific markets where rapid industrialization and regulatory modernization are creating unique opportunities for quality technology implementation.

Salary Evaluation

The offered salary range of SGD 5,000-6,000 monthly (approximately SGD 60,000-72,000 annually) is competitive for Singapore's market, particularly considering the contract nature of the position. For permanent roles with similar responsibilities, the range would typically be SGD 80,000-100,000 annually. The contract premium and specialized skill requirements justify this compensation level, especially given Singapore's position as a regional hub for pharmaceutical and biotechnology operations.

Role Significance

Typically manages or influences teams of 8-15 professionals across quality assurance, IT, and compliance functions. The role involves extensive cross-functional collaboration and may include direct supervision of junior quality engineers, validation specialists, and system administrators. The position often serves as a technical lead for project teams ranging from 5-20 members during major system implementations or validation projects.
This role represents a mid-to-senior level position with significant technical leadership responsibilities and cross-functional influence. The incumbent serves as a critical bridge between IT and quality operations, with direct impact on regulatory compliance and operational efficiency. The position requires both deep technical expertise and strategic thinking capabilities, positioning the role holder as a key contributor to organizational quality strategy and digital transformation initiatives.

Key Projects

Implementation and validation of enterprise-wide electronic quality management systems, often involving multi-million dollar technology investments and 12-18 month deployment timelines Leading regulatory compliance initiatives for computerized system validation, ensuring adherence to global standards while optimizing operational efficiency Driving data integrity transformation projects that establish comprehensive audit trails and automated compliance monitoring across manufacturing and quality operations Managing quality system integration projects that connect disparate manufacturing, laboratory, and business systems into cohesive digital ecosystems Leading preparation and execution of regulatory audits and inspections, ensuring organizational readiness and successful outcomes

Success Factors

Deep technical expertise in both quality management principles and information technology systems, enabling effective translation between business requirements and technical solutions while maintaining regulatory compliance integrity Exceptional project management and change management capabilities, as the role involves implementing complex technology solutions that require significant organizational adaptation and user training across multiple departments and functions Strong analytical and problem-solving skills with the ability to synthesize complex regulatory requirements into practical system configurations while identifying and mitigating potential compliance risks before they impact operations Excellent communication and stakeholder management abilities, as success requires building consensus among diverse groups including senior management, IT professionals, quality teams, regulatory affairs, and external auditors with varying priorities and technical backgrounds

Market Demand

Demand for IPQA Project Engineers with digital quality systems expertise is exceptionally high in Singapore and across Asia-Pacific markets. The convergence of regulatory modernization, digital transformation initiatives, and the region's growing pharmaceutical manufacturing sector creates a highly favorable job market for professionals with these specialized skills.

Important Skills

Critical Skills

Expertise in electronic quality management systems (eQMS) platforms like TrackWise and SAP QIM is absolutely essential, as these systems form the backbone of modern pharmaceutical quality operations. Proficiency in these platforms directly impacts an organization's ability to maintain compliance, manage quality workflows, and respond to regulatory inquiries efficiently. Deep understanding of regulatory frameworks including 21 CFR Part 11, EU Annex 11, and ICH guidelines is critical for success, as these regulations govern every aspect of computerized system implementation in pharmaceutical environments. This knowledge ensures that all system configurations and validation activities meet stringent regulatory requirements. Advanced data analysis capabilities using tools like JMP, Minitab, and SPSS are crucial for transforming raw quality data into actionable insights. These skills enable the identification of quality trends, risk assessment, and the development of data-driven strategies for continuous improvement. Computerized Systems Validation (CSV) expertise is fundamental, as it ensures that all digital quality systems meet regulatory requirements while supporting business objectives. This knowledge protects organizations from regulatory citations and ensures system reliability and data integrity.

Beneficial Skills

Six Sigma Green Belt certification and experience with Lean methodologies enhance the role's impact by providing structured approaches to process improvement and waste reduction in quality operations, leading to measurable business value creation Experience with emerging technologies such as artificial intelligence, machine learning, and predictive analytics in quality applications positions professionals at the forefront of industry evolution and increases long-term career value Project management certification and experience managing large-scale technology implementations demonstrate leadership capabilities and increase opportunities for advancement to senior management roles Cross-functional business acumen including understanding of manufacturing operations, supply chain management, and commercial operations enables more strategic thinking and broader organizational impact

Unique Aspects

The role combines deep regulatory expertise with cutting-edge technology implementation, creating opportunities to work at the forefront of pharmaceutical industry digital transformation while building expertise in both domains simultaneously
Singapore's position as a regional pharmaceutical hub provides exposure to diverse regulatory frameworks, international best practices, and emerging market dynamics that enhance professional development and market value
The contract nature of the position offers flexibility and potentially higher compensation while providing exposure to multiple client environments and industry sectors within the regulated space
The role involves direct interaction with senior executives and regulatory authorities, providing unique networking opportunities and visibility into strategic decision-making processes that can accelerate career development

Career Growth

Career progression to senior management roles typically occurs within 3-5 years for high-performing individuals, particularly those who successfully lead major digital transformation projects and demonstrate strong business acumen alongside technical expertise. Movement to director-level positions often requires additional experience in budget management, strategic planning, and regulatory relationship management.

Potential Next Roles

Quality Systems Manager or Director, overseeing comprehensive quality technology strategy and managing larger teams of quality professionals across multiple sites or business units Digital Transformation Lead for Quality Operations, focusing on enterprise-wide implementation of advanced analytics, artificial intelligence, and predictive quality systems across global operations Regulatory Affairs Technology Director, specializing in the intersection of regulatory compliance and digital technology implementation for pharmaceutical and biotechnology companies Quality Assurance Vice President or Head of Quality, taking on executive responsibility for quality strategy, regulatory relationships, and organizational quality culture development

Company Overview

COMBUILDER PTE LTD

COMBUILDER PTE LTD operates as a specialized technology consulting and implementation firm serving pharmaceutical, biotechnology, and regulated industries across the Asia-Pacific region. The company focuses on digital transformation initiatives, particularly in quality management systems and regulatory compliance technology. Their expertise spans system integration, validation services, and regulatory consulting, positioning them as a strategic partner for companies navigating complex compliance requirements while modernizing their operations.

The company occupies a niche but important position in Singapore's growing life sciences technology sector, serving as a bridge between global pharmaceutical companies and cutting-edge digital quality solutions. Their specialization in regulated industry technology implementation provides competitive advantages in a market where regulatory expertise and technical capability must be seamlessly integrated.
Singapore serves as an ideal base for COMBUILDER's operations, leveraging the city-state's position as a regional hub for pharmaceutical manufacturing and biotechnology innovation. The company's location provides access to multinational pharmaceutical companies establishing Asian operations, local biotechnology firms seeking to expand internationally, and regulatory agencies modernizing their oversight approaches.
The company culture likely emphasizes technical excellence, regulatory precision, and client service delivery, given the high-stakes nature of pharmaceutical quality systems implementation. The contract-based nature of this position suggests a project-focused environment where professionals work on discrete, high-impact engagements with clear deliverables and timelines.
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