Sphere Healthcare is a leading Australian-owned contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.

 

We are seeking a Validation Associate, who displays initiative and is self-motivated, to join our close-knit and highly skilled team.  The successful candidate will execute validation protocols for manufacturing processes, perform qualification activities on existing equipment and work with key internal stakeholders to ensure any new equipment is qualified in a timely and compliant manner.

 

 

Role Responsibilities:

Ø  Review and approve GMP validation documentation to ensure compliance with regulatory requirements and best practice

Ø  Assist with Risk Assessment Processes to support the business

Ø  Generate validation protocols and reports ensuring practices meet TGA requirements

Ø  Validation Protocol Preparation including URS, DQ, IQ, OQ & PQ

Ø  Maintenance of Validation Project Plans, including Site Validation Master Plan

Ø  Assist in the management of validation activities associated with changes to existing and new processes

Ø  Execution of Validation activities and report preparation

Ø  Develop validation plans, SOPs, programs and policies

 

Key Requirements:

Ø  Tertiary qualified in either Science, Engineering or related discipline

Ø  (Graduates in their final year will be considered for this role)

Ø  Previous experience within the Pharmaceutical or Complementary Medicines industry an advantage

Ø  Knowledge of, and ability to interpret validation principles and regulatory

requirements

Ø  Experience in process, cleaning and equipment validation

Ø  Knowledge of continuous improvement and risk based methodologies

Ø  Excellent Communication and Organisational skills

Ø  Demonstrated effective Project Management and superior Computer Literacy

 

Sphere Healthcare is an equal opportunity employer that values diversity.  This is a great opportunity for someone with good experience to join our hardworking team and we encourage all suitable applicants to apply.

If you feel you have the above experience and skill set, submit your covering letter and resume to: hr@spherehealthcare.com.au.

Only applicants selected for interview will be contacted.

All other applicants are thanked for their interest.

Posted
AuthorAnnette Stuccio