Senior Specialist, Quality Assurance (Validation)

As a Senior QA Specialist, you will support day -to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GMP contract manufacturing facility.

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:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

• In depth awareness of entire process, identifying operational factors which influence the process.

• Lead a small team and provides supervision to QA Coordinators, interns or QA Specialists.

• A competent Reviewer and Approver of SOPs, protocols, reports or records

• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.

• Demonstrate ability to lead a small project and manage the deliverables effectively.

• Develop good working relationships with internal & external customers.

• Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.

• Develop skills as an internal GxP auditor, as required.

• Provide support in regulatory inspections and customer audits as required.

• Plan for future activities and coordinate with other departments to complete this.

• Develop skills to be Qualified Trainer in area of expertise.

• Any other tasks as and when assigned by supervisor.

​What we’re looking for:

• Degree in Biological Science / Engineering and experience in Validation / Quality unit in the Biopharmaceutical industry.  

• 3- 5 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

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