QA Commercial Associate - Horsham, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Verified Company
Horsham, United Kingdom

3 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Job T
it
le
:
QA Commercial Associate

Po**s
it
ion L**o
ca**t
io**n
:
Hor
sh
am**Thermo Fisher Scientific Inc

(NYSE:

TMO) is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.


When you're part of the team at Thermo Fisher, you'll do outstanding important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and you'll be supported in achieving your career goals.


How will you make an impact?


As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer_.

_


What will you do?
You will be part of a quality unit which is focused on commercial operations. You will build working relationships to ensure operational excellence and high employee engagement across shifts.

You will ensure the batch documentation is complete and passed onto the Qualified Person to ensure that compliant medicinal product is sent to the patient.

**Resp
onsibilit
ie
s:

  • Batch Record Review and working with operations to ensure there is no delay in having the commercial batches passed onto the Qualified Person at TFS,H.
  • Familiarity with systems such as Trackwise, Documentum and SAP etc.
  • Assistance in creating new batch records for new clients and products.
  • Assistance in creating / update procedures to ensure these are fit for purpose.
  • Assist investigation of deviations associated with packaging, ensuring that issues are appropriately identified and resolved, referring to management where appropriate.
  • Resolution of client observations on deviations post approval.
  • Resolution of client observations on batch records following postproduction review.


  • Audits

  • Assist in internal, supplier and client audits.


  • Training

  • Assist n the training of employees in Quality related processes.
  • Perform other duties as requested by line management.

How will you get here?

Minimu
m Req**u
ir
em**en**t
s/**Q**ual
if**ic**a
tio**n
s:


  • Extensive knowledge of GMP environments.
  • Able to analyse problems and define solutions.
  • Able to work under pressure and to support others within the team.
  • Good communication skills both internally and externally.
  • Ability to work without direct supervision / on own initiative within the remit of the role.

Exp
er**ien
ce
req**u
ir
ed of
/in**:


  • Secondary Packaging Batch Record review within a pharmaceutical setting.
  • Experience working within the pharmaceutical sector, or another lifecycle sector.
  • Experience working with Operational colleagues and the ability to resolve discrepancies within batch records.
  • High degree of accuracy, concentration, verbal and written communication.
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