Job: Associate Director – Validation (Pharmaceutical sector)

Location: Adelaide, SA 5000

About the Job

Hospira is a global speciality pharmaceutical and medical delivery company employing 16,000 people worldwide.  Driven by its vision of Advancing Wellness and providing proven leadership within the sector, Hospira delivers solutions to help improve the productivity, safety and effectiveness of patient care.

As part of Hospira’s Adelaide business which employs around 100 people in a single site location, this role is responsible for ensuring effective, efficient and compliant validation is achieved and maintained across all validation disciplines.

This role reports directly to the Quality Director and will be responsible for leading, managing and developing the validation team.

The successful applicant must have a strong background of working in a similar role within a Quality team in the pharmaceutical sector. 

Key Responsibilities:

·        Manage the validation team, providing technical advice and performance feedback to enable achievement of individual, team and site goals

·        Provide validation expertise  and guidance to key internal and external customers as required.

·        Ensure validation procedures are in place as per current Regulatory and Corporate requirements for validation of biologic drug substances (API) together with qualification of equipment, processes, infrastructure, computerised systems and analytical methodology.

·        Liaise with members of the product development teams to generate process design including  validation plans, protocols, and reports.

·        To participate in Quality related projects and deliver on the validation aspects of these projects.

Essential requirements:

·        You must have a strong background within the biopharmaceutical sector together with a solid track record of leading a quality team.

·        In depth knowledge of cGMP including ICH Q7 and international codes of GMP.

·        You will have a science related degree .

·        Demonstrated work experience with companies operating in highly regulated environments.   

·        Excellent attention to detail skills are essential.

·        Able to problem solve and create the most effective corrective actions.

·        First class communication skills – both written and verbal are essential.

In return, we offer an excellent salary, bonus, working visa and relocation.  We also offer outstanding career opportunities both within Australia and also across all our operating countries internationally. 

More Info and Application