Senior QA Operations Specialist
2 days ago
Company Overview
Lonza is a global leader in life sciences, operating across three continents. Our success lies in talented people working together to devise innovative solutions that help businesses improve lives worldwide.
As the first biologics contract manufacturer in Singapore, we offer exposure to emerging biotech and established pharmaceutical companies, as well as cutting-edge manufacturing technology for mammalian treatments and cell therapies.
We are proud to be part of Lonza's global network, recognized for our reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms, and extensive experience.
About the Role
The Senior QA Operations Specialist will support day-to-day Quality Assurance activities at our multi-product, cGxP contract manufacturing facility. This role involves:
- Monitoring Quality Assurance activities according to approved SOPs and policies.
- Reviewing and approving SOPs, protocols, reports, and records.
- Participating in cross-functional site teams on projects and issues.
- Coordinating between departments for multiple parallel activities.
- Troubleshooting and developing improvement strategies.
This position requires a highly motivated individual with superior skills in all areas relevant to the job, as well as excellent communication and problem-solving abilities.
Requirements
To succeed in this role, you will need:
- A degree in science or a related field.
- Relevant work experience in the Pharmaceutical Manufacturing industry or Validation/Quality unit in the Biopharmaceutical industry.
- Familiarity with regulatory requirements and local codes and standards (e.g., FDA, EMEA, and ICH Q7).
- Knowledge and experience of quality management systems in GMP facilities.
- Excellent team player skills, with a strong focus on safety, quality, and timelines.
Salary: $80,000 - $110,000 per annum, depending on qualifications and experience.
What We Offer
At Lonza, we respect and protect our people and the environment. We believe that business results should not come at the expense of ethics. Join us in making a meaningful difference in people's lives.
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