QA Specialist 2 - Singapore - Lonza Biologics Porriño SLU

Description

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

QA

Specialist will support day-to-day Quality Assurance activities in accordance

to

the area of

Quality Operations


Key Responsibilities:
Review completed


GMP
records to ensure compliance with c
GMP per written procedures ( e.g.

manufacturing critical logbooks, batch records, changeover records)Review and approve


SOP
related to batch record/logbook

review.
Participate and support improvement projects related to Manufacturing process

operation.
Participate in walkthroughs and internal audit

program.
Provide support in regulatory inspections and customer audits as

required.
In depth awareness of entire process,

identifying

operational factors which influence the

process.
Plan for future activities and coordinate with other departments to complete the planned

activities.
Make real-time decisions on process events on the floor based on knowledge of defined


SOPs

and

policies.
Develop good working relationships with internal and external

customers.
Compile batch documentation for lot release within targets defined by review and release

schedule.
Support

timely

completion of Annual Product ReviewsSupport training to new team members and

manufacturing.
Any other tasks as and when assigned by

supervisor

Key Requirements:
Bache

lor's degree

with

relevant work experience in Quality Assurance in the Biopharmaceutical industry.
Relevant QA Operations background from the Biopharma environment.
Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
Receive minimal supervision and able to perform independently on routine

assignments.
Fair knowledge and experience of the practical and theoretical

requirements

of quality management

system

in a
GMP facility.
Familiarity with Regulatory requirements and local Codes & Standards ( e. g.,

FDA,


EMEA
, and lCHQ7).Meticulous and Systematic

with

Good oral and written communication skillsTeam player, 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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