Senior Specialist, QA (Technical Support )

Posted 6 Days Ago
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Singapore, SGP
In-Office
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
Provides day-to-day QA support for a biopharmaceutical manufacturing facility, reviewing and approving GMP documentation, deviations, investigations, CAPAs, change controls, validation activities, and quality events. The role supports audits, data integrity, process improvements, changeovers, and risk-based quality decisions. It leads small projects, coordinates cross-functional activities, trains and guides junior QA staff, and provides QA oversight for operational and process changes.
Summary Generated by Built In

 

As a Senior QA Specialist, you will support the QA technical support team .

This is a fully site‑based role at Singapore Tuas. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you’ll get

  • An agile career and dynamic working culture in a global life sciences leader.

  • An inclusive and ethical workplace that values diversity and integrity.

  • Competitive compensation programs that recognize high performance.

  • Professional growth opportunities through cross-functional projects and global exposure.

  • Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.

  • Company transport provided from designated MRT locations to and from the Tuas site.

  • Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits

What you’ll do:

  • Provide day-to-day QA support for a multi-product cGxP manufacturing facility in accordance with SOPs and policies.

  • Review and approve deviations, investigations, CAPAs, change controls, SOPs, protocols, reports, MBRs, and other GMP documents.

  • Ensure effective root cause analysis, timely CAPA implementation, and closure of quality events.

  • Identify and escalate cGMP/GDocP non-compliance and provide guidance on corrections.

  • Support changeover activities and provide QA oversight for operational and process changes.

  • Participate in regulatory and customer audits.

  • Troubleshoot quality issues and make sound decisions based on risk and available information.

  • Lead small projects and coordinate activities with relevant departments to meet deliverables.

  • Build effective relationships with internal and external stakeholders and provide guidance to junior QA staff.

  • Support data integrity initiatives and proactively identify opportunities for process improvement.

  • Develop expertise as a qualified trainer and act as a reviewer, approver, or change agent as required.

  • Provide support for QA review of validation activities, including VMP, PPQ, supporting studies, validation protocols/reports, and CPV.

  • Perform other duties as assigned by the supervisor.

What we’re looking for:
  • Degree in Biological Science / Engineering and experience in Quality unit in the Biopharmaceutical industry.  

  • 3-4 years of experience in a similar type of industry or a similar job role.

  • Able to operate independently with minimum supervision.

  • Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility

  • Team player, with strong focus on safety, quality and timelines

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

 

Skills Required

  • Degree in Biological Science or Engineering
  • 3-4 years of experience in the biopharmaceutical industry or a similar QA role
  • Experience working in a quality unit within the biopharmaceutical industry
  • Ability to operate independently with minimum supervision
  • Practical and theoretical knowledge of quality management systems in a GMP facility
  • Team-oriented approach with a strong focus on safety, quality, and timelines
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The Company
HQ: Basel
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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