QA Officer

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific every one of our 75000 unusual minds has a distinct story to share. Join us and contribute to our outstanding missionempowering our customers to make the world healthier cleaner and safer.

Job Title: Quality Assurance Officer

Reports to: Supervisor Quality Systems

Group / Division: Pharmaceutical Services Group (PSG)/ Drug Substance Division (DSD or equivalent experience)

Career Band: 4

Job Family: Operations (OPS)

Job Sub Family: Quality Assurance (QAOP)

Job Code: .P04

Job Track: Professional

Position Location: Brisbane Australia

Position Summary:

Brisbane site develops & manufactures biopharmaceutical products for clinical trials and commercial use.

This candidate will join our outstanding Quality systems team and assist the Validation and Engineering team with quality support. If this sounds like you wed love to hear from you!

Key Responsibilities:

• Reviewing and approving Process Validation / Equipment Validation documents promptly including Microbial Mapping validation protocols resin re-use protocols cleaning validation protocols new equipment etc.
• Active participant in deviation investigations.
• QA Approval of quality records including but not limited to; Deviations CAPAs Audit findings etc.
• Reviewing and endorsing QA controlled documents within the Quality Management System.
• Supports compliance to systems timeframes for raising processing or performing associated tasks (i.e. Change Control actions DR investigations processing CAPAs).
• Issuing protocols as required to other departments.
• Updating SOPs and other documents to meet current regulatory and corporate standards.
• Serving as a resource to the operational areas on quality-related issues.
• Identification of continual improvement opportunities.
• Participating in Risk Assessments.
• Any other legitimate duties requested by QA Manager.

Frequent Contacts:

Internal: Validation Engineering Process Engineering

External: Clients and Regulatory Agencies

Minimum Requirements/Qualifications:

Qualifications & Experience

• Tertiary Academic level in a relevant field (Biotechnology Biochemistry Microbiology Chemistry Pharmacology or equivalent).
• At least 3 years of experience in a GMP regulated setting.
• Ideally at least 1 year of experience in Quality Assurance within a GMP-regulated setting is preferred.

Skills & Attributes

• Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
• Strong communication skills.
• Strong written verbal and presentation skills.

Other Job Requirements:

• Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment.
• Ensure hazardous conditions hazardous actions incidents and near-miss incidents are reported.
• Not knowingly pollute the environment.