Expert QA (Data Integrity)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a QA Expert (Data Integrity) you will ensure good data integrity practices for all data generated at the site are embedded across all GMP functions at the Singapore site. The individual will be responsible to develop and oversee execution of the site Data Integrity Plan in alignment with global DI plans. This role will be working in partnership with various stakeholders on site (MFG, ENG, IT, QC, other QA functions) and global DI network.

Key responsibilities:

• Lead the Data Integrity Program for the site and act as an SME regarding Data Integrity for the site.

• Develop site Data Integrity Plan including prioritised activities, responsibilities and timelines for activity completion.

• Ensure data quality and consistency within the site through monitoring to meet the stated Lonza and regulatory requirements.

• Follow data integrity notification process when problems arise.

• Reduce the risk of regulatory findings / observations related to data integrity.

• Lead the Data Integrity Risk Assessment and support the site to create Corrective and Preventative Actions against the assessment.

• Drives site remediation efforts and communicates delays to site Quality Council and Global DI Leads.

• Work with site personnel to continually identify and leverage opportunities to improve the quality of data management and how to protect it securely.

• Active member of Global DI network and participate in DI Forum to share approaches with similar sites with corporate/regulatory requirements.

• Engage and Partner with other DI leads for Lessons learned and concerns.

• Contribute in group tracking for DI issues and Roll out Data Integrity training and suggest improvements.

• Participate in gap assessments to ensure regulatory findings at Lonza and in industry and are monitored and corrected.

• Taking part to trouble shooting or improvement program and initiatives

• Representing Quality in the respective global standards definition and implementation

• Being a Subject Matter Expert (SME) in Data Integrity

• Representing of Quality in various CAPEX projects teams

• Any other tasks as and when assigned by the superior.

Key requirements:

• Degree in Science related from recognized institution with extensive years of experience in Quality unit in the pharmaceutical/biotech industry.

• Good knowledge and experience of the practical and theoretical requirement of validation program including Data Integrity in GMP facility.

• Good appreciation of cGMP in biopharmaceutical manufacturing.

• Experience with pharmaceutical Quality Systems including change control, deviation and CAPA.

• Familiarity with Regulatory requirements and local Codes & Standards (e.g. ISPE, 21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each and ICHQ7).

• Good leadership and interpersonal skills.

• Good communicator, able to articulate complex information concisely and with sensitivity to the audience at hand and to build effective relationships with internal customers and supporting functions such as QC, QA, Engineering and Operations.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.