Job Details: QC Lab Lead/Microbiology and Stability


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Jervis Street
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QC Lab Lead/Microbiology and Stability
Position:  QC Lab Lead (Microbiology and Stability)
The job:

Thermo Fisher Scientific are looking to hire a Mechanical
Craftsperson, to be based at our Cork manufacturing site.

The purpose of this job is to lead the microbiology and stability
activities within the QC team thereby ensuring that internal and
external customer requirements are met. The QC lab leader (Micro and
Stability) will also participate in identifying resource requirements
(personnel, equipment and facilities) for the QC group, participate in
the recruitment of personnel for the laboratories and develop the
strengths/talent of team members and ensure that group and individual
training requirements are met.

Operating for over **Apply on the website** years, the Cork site is
proud to manufacture and supply Active Pharmaceutical Ingredients
(API) to our customers for use in clinical trials and approved
medicines for commercial supply - medicines to treat Cancer,
Parkinson’s Disease, Depression, HIV, Congestive Heart Failure,
Diabetes and Respiratory diseases, along with raw material for
consumer healthcare products.

The Cork site is welcoming exciting growth and new expansions to
support much-needed capacity for APIs currently in development and the
increasing needs of customers and the patients we serve.

What will you do? Responsible for Microbiologists & stability chemists
within the QC department.

Oversee the Microbiology lab, ensure the testing requirements are met
and the lab is maintained to an inspection ready standard

Oversee the stability program and provide support to internal and
external customers.

Collaborate closely with other teams on site to plan and coordinate
testing and disposition activities for the QC laboratory.

Provide support to the Stability Chemist for management of Stability
program and ensure that Stability testing is carried out within the
permitted timelines.

Carry out a review of Stability data for regulatory submissions and
Annual reports as the need arises.

Provide support for the microbiologists on testing, ensuring the
agreed plan can be achieved

Generate, Review and Approval of change controls, CAPA’s, deviations
etc, as required

Review and approval of GMP documentation e.g. equipment qualification,
procedures, protocols/reports etcCarry out monthly review of
Laboratory Investigation Reports for the labs

Provide support for engineering and production on all microbiology
issues are required.

Generate reports, metrics and other documentation to support the lab
program.

Communicate any outstanding quality issues to the QC manager as
appropriate.

Prepare and support Quality group for internal and external audits

Be flexible and willing to adapt to business needs in a fast pace and
changing CDMO environment, serving multiple customers.

Who we are looking for: BSc Hons Degree Science, and/or higher degree

Knowledge of and participation in inspections, audits and reviews of
operations and processes is required.

Knowledge of lab systems

Detailed knowledge of the cGMP requirements relevant to the role and
understand the GQMPs and GQPs that relate to the role.

GMP competent as applied to the laboratory environment

Relevant experience within the pharmaceutical industry is preferred.

What’s in it for you:

Competitive base salary

Annual bonus

Contributory Pension

Private medical insurance

Free onsite parking

ABOUT US:

Thermo Fisher Scientific Inc. is the world leader in serving science,
with annual revenue exceeding $**Apply on the website** billion. Our
Mission is to enable our customers to make the world healthier,
cleaner and safer. Whether our customers are accelerating life
sciences research, solving complex analytical challenges, improving
patient diagnostics and therapies or increasing productivity in their
laboratories, we are here to support them.

Our global team of more than **Apply on the website**,**Apply on the
website** colleagues delivers an unrivaled combination of innovative
technologies, purchasing convenience and pharmaceutical services
through our industry-leading brands, including Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services
and Patheon.

With Thermo Fisher Scientific, it’s not just a career. It’s a
chance to realise your best – professionally and personally.

Apply today! (Use the "Apply for this Job" box below). Fisher
Scientific is an EEO/Affirmative Action Employer and does not
discriminate on the basis of race, color, religion, sex, sexual
orientation, gender identity, national origin, protected veteran
status, disability or any other legally protected status.

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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