Validation Team Leader

3 days ago

Auckland, Auckland, New Zealand Technical Recruitment Solutions Ltd Full time
  • Well regarded NZ pharmaceutical business
  • Opportunity to develop your skills and long term career
  • Stable employment

About the company

Our Auckland-based client, an established player in the New Zealand pharmaceutical market, is looking an experienced Validation Engineer with leadership experience for their ever expanding business. With this company manufacturing a large range of products to cGMP standards, and continued capital expansion of their manufacturing plant to meet expected future demand, they have need for professional with validation experience across all fields but with particular focus on equipment and process validation for their utilities and production areas.

About the role

Reporting to the Validation Manager, this is an important role within the validation team whereby you, the incumbent, will work directly to complete specific routine and new validation projects as well as supporting the junior members of the team as they grow and develop. Scope of the role will cover all aspects of validation within a pharmaceutical manufacturing plant and you will be expected to have experience in this from other cGMP facilities either in NZ or internationally.

As a suitable applicant

As a preferred candidate, you will need to have a solid base with a minimum of 5 years process and equipment validation experience within pharmaceutical or medical device manufacture. You'll be able to manage a validation master plan, write, execute and approve validation protocols (IQ, OQ, PQ and well as DQ and SQ if possible), and be fully conversant with regulatory requirements as specified by Medsafe, FDA or similar. You will need to be able to work independently as a subject matter expert but also engage with and support other members of the validation team. You'll also be adept at working cross-functionally with other teams so as to manage your workload and deadlines alongside theirs for a mutually successful outcome.

Skills/experience

  • Tertiary qualification in a relevant scientific field
  • 8+ years experience in process validation including IQ/OQ/PQ and preferably DQ/SQ
  • Experience in leading and mentoring others in a cross-functional environment
  • Experience in a cGMP environment – pharma or medical devices
  • Proven ability to build and maintain strong cross-functional working relationships
  • Strong time management skills, able to see and resolve potential issues
  • Broader QA and GMP experience within a pharmaceutical (or equivalent) environment
  • Able to support and mentor colleagues
  • Computer literacy

Culture

Our client is a fast paced and supportive business where you are expected to do your bit but in return they offer a competitive salary with benefits, mentored career development and opportunities to work for a highly respected NZ employer.

How to apply

For a confidential enquiry or to apply for this position please click on the
APPLY
button below, alternatively contact
Tony De Barr
on

, email

.

Note: If this vacancy is not exactly what you are seeking, then please contact me in confidence to discuss your individual requirements.

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