Job Description

Description

This role will be responsible for
coordinating, facilitating, and undertaking activities pertaining to transfer
of analytical methods to international government / contract labs as part of the
global sales expansion. The role also represents the QC unit by liaising with
internal and external customers.

 

• Supporting drug product
analytical method transfers to international government / contract labs as part
of the  global sales expansion.

• Management of various aspects
of the analytical method transfer process (e.g. tracking of transfer
milestones, preparation and approval of analytical method transfer plans and
reports and ensuring adherence to transfer requirements).

• Completing subject matter
expert data review of International lab method run results where required.

• Providing analytical support
for drug product registration/import testing in International labs, through
management of the shipment reference standards, critical reagent and commercial
materials.

• Working collaboratively with
other functions within the network and international labs (e.g. International
Quality, Regulatory, Supply Chain and Logistics).

• Support the management team with
the visual management board and tracking KPIs for the IAS group.

• Competent in the use of
document management systems such as EDMQ/CDOCS


Requirements

Qualification and Skills

• Third level qualification (Degree/Diploma) in
Biochemistry, Chemistry, Biology or Biotechnology.

• Have at least 2 years relevant experience in a
pharmaceutical/healthcare environment.

• Proficient in the use of Microsoft Word, Excel etc.

• Strong technical writing skills.

• Detail oriented, self-motivated with good troubleshooting
and problem solving abilities.

• Self-starter and capable of working on own initiative.

• Strong team work skills.

• Proven track record of meeting deadlines.

• Experience with analytical techniques such as HPLC,
Bioassay and Compendial testing would also be advantageous

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