Documentation/Quality Specialist
- Join a well-established pharmaceutical company as a Documentation/Quality Specialist.
- Develop and evaluate quality and system procedures to ensure compliance.
- Collaborate with internal teams and liaise with stakeholders.
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
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letterAND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Sarah on ************.
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