Senior Specialist, Compliance (Audit Management), QA
Full-time
Senior Executive
11 months ago
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 ..
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.
The Senior QA Specialist will lead and support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for multi-product s and also provides QA support for Audit Management.
Responsibilities:
Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility.
Highly motivated individual and have superior skills in all areas relevant to the job.
Member of cross-functional site team(s) on projects/ issues.
Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.
Superior ability to troubleshoot.
A competent Reviewer and Approver of SOPs, protocols, reports or records.
Able to coordinate between departments for multiple parallel activities.
Understanding of advanced topics pertaining to cGMP.
Participate in Customer / Agency Audits and Inspections as required.
Identify process pathways and work to develop improvements in strategy.
Help/Transfer and quickly assimilate to leadership role in other process areas.
Assume Supervisory responsibility in absence of supervisor
Understands and articulates company business strategy. Maintains a broad view of the
business, recognize changes and trends in the appropriate area in which the individual
operates.
Any other tasks as and when assigned by supervisor.
Requirements:
Engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry
Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
Good interpersonal skills
Effective Communicator (oral and written)
Exhibit good quality decision making traits
Meticulous, Systematic and Analytical Mind
Team player who can operate independently, with strong focus on safety, quality and timelines.
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.
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