About the company/role:
* Well-established pharmaceutical company seeking a Documentation/Quality Specialist to join their team
* 6-month contract
* Onsite, full-time hours (Mon-Fri)
* Normal business hours
* Based in South Eastern suburbs
Duties, but not limited to:
* Develop and evaluate quality and system procedures to ensure reliability, usability and compliance
* Write procedural documentation such as SOPs, work instructions and forms
* Collaborate with internal teams across departments and liaise with SMEs to extract information
* Review batch release documentation
* Review/approval revalidation and requalification reports and documentation
* Administration and maintenance of Quality Management Systems
* Performing visual inspections on intermediate and finished products
* Assist in the preparation of summary protocols and batch release documentation
* Liaising with both internal and external stakeholders
Skills/experience:
* Tertiary education in a relevant science discipline (Chemistry, Biochemistry, Pharmaceutical, Biology or similar)
* 3 years in a GMP environment within pharmaceutical, biotech or other highly regulated environment
* Demonstrated experience working as a Quality Associate/Validation Associate within a GMP environment
* Knowledge of TGA, FDA, EMA requirements
* Good interpersonal, analytical and problem‐solving skills
* Ability to work well independently and in a team
* Great organisational and time management skills
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