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Quality System Specialist

3 weeks ago

Singapore Amaris Consulting Full time

**Job description**:
**About **the** **job**:

- Monitor the QMS for compliance with procedures, and completion of deliverables according to committed timelines.
- Prepare reporting information for Change Control Review Board and Investigation Review Board.
- Identify, investigate, and resolve complex technical issues using problem-solving skills. Notifies management of actions taken.
- Analyze and interpret projects, studies, or investigations to determine next steps. Make decisions and notify management of action taken.
- Write new documents and revise existing documents, independently.
- Perform QA review/approval of controlled documents.
- Provide support to site personnel performing Deviation Investigations, CAPAs, and Change Controls.
- Receive overall project direction from management but complete most work independently.
- Participate in internal or supplier audits.
- Develop and provide training on department-specific procedures and systems.
- Participate in required training and keep training files current.
- Identify, propose, and implement Quality Process and system improvements.
- Complete mandatory training within the required timeframe.

**About you**:

- Bachelor’s degree in Chemistry, Chemical Engineering Science or related technological field.
- 4-6+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry.
- Experience in manufacturing equipment, computer system validation and Quality Management Systems.
- Experience to Reviews, Approve validation lifecycle documentation, e.g. IQ, OQ, PQ protocols and reports.
- Hands-on experience in performing equipment validation, computer system validation.
- Knowledge in 21CFR Part 11 and GAMP5.
- Experience in coordinating and managing cross-functional for the post-execution review, discrepancy management, status reporting and post-execution approval of all validation documents, SOPs, change control.
- Review and Approve routine SOP, FORMs and any relevant procedures that is impacted by QC LIMS and MODA systems.
- Experience to Reviews, Approve computer system validation lifecycle documentation, e.g. risk assessments, technical specifications.
- Knowledge in recombinant processes under GMP environment.
- Knowledge in Process Control Systems, preferred Siemens PCS7 platform.
- Able to logically solve problems in order to find timely solutions.
- Language: Excellent command of English.

**Equal opportunity