Validation Specialist

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Located in Boronia one of our leading pharma manufacturing site is an excellent opportunity for a Validation Specialist to join the quality team.

Summary about this job

Quality Assurance & Control

Company: GlaxoSmithKline

Location: Melbourne

Work type: Contract/Temp

Salary: n\a

Phone: +61-7-8342-9541

Fax: +61-8-4473-8418

E-mail: n\a

Site:

Detail information about job Validation Specialist. Terms and conditions vacancy

  • Key Validation role – 6-month contract
  • Australian Healthcare Leader
  • On-site parking, canteen, gym

GlaxoSmithKline is a global research-based pharmaceutical and consumer healthcare company with a proud history in Australia. On a daily basis our products make a difference to millions of people’s lives. Our manufacturing teams are responsible for making and shipping the products that help people do more, feel better and live longer.

The role:

Located in Boronia at our market leading pharmaceutical manufacturing site, we have an excellent opportunity for a Validation Specialist to join the Quality team for 6-month contract. The purpose of this role is to ensure only safe, effective and consistent product is released to the market through the implementation of a robust, compliant and risk based processes.

Responsibilities include:

  • Accountable for the standard of validation required for manufacturing facilities, materials, processes and systems used in the manufacture and control of drug products; including validation input into the site planned change process.
  • Contribute to the validation of automated process equipment with IT and Stream Engineering. This includes the generation of Compliance Determinations, GxP impact assessments and the determination of Electronic Records/Electronic Signatures implications.
  • Perform all routine re-qualification and re-validation activities according to specific protocol requirements on time and in line with customer requirements.  This includes working flexible hours in order to cater to production shifts and being accessible to production staff.
  • Accountable for coordinating validation batches with the planning and site change functions.  This includes being accountable for managing and ensuring that all tasks are completed on time meeting all compliance requirements.
  • To be customer focussed by pro-actively engaging key customers such as manufacturing departments to obtain feedback, highlight potential supply issues etc. This includes working flexible hours in order to cater to production shifts and being accessible to production staff.
  • Support root cause investigations aimed at defining and optimising processes or trouble shooting production problems.  Determine and support the implementation of CAPA actions resulting from investigations.
  • As Change Owner of Planned Changes, be responsible for managing the changes end to end as per Change Owner responsibilities detailed in the Planned Change GMS Boronia SOP.
  • Take responsibility to ensure that IT projects are carried out in accordance with ITMS/CSQMS methodology and are documented and, where appropriate, validated to an appropriate standard

About you:

With a keen eye for detail, you will be an analytical thinker with previous experience working in the pharmaceutical sector. The successful applicant will have worked in a quality focussed role (preferably with some validation experience) either within the lab/manufacturing or engineering and in the pharma or food industry. Not content with accepting the status quo, you will be confident to question processes and create improvement initiatives to drive performance.

 

In return:

In return, we can offer you a rewarding culture that values you, focuses on your career progression, and makes you an integral part of our success. To become part of our team please apply online now. Successful applicants will be notified of next steps.

 GSK does not accept applications from third party channels.

*LI-GSK

 

 

 

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