Specialist - QA Ops - Manufacturing Mgmt
2 days ago
**Summary**:
Job Description Summary
This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site objective/s.
**About the Role**:
Position Title: Specialist - QA Ops - Manufacturing Mgmt
Location - Singapore
About the Role:
This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.
Key Responsibilities:
- Ensure all activities in compliance with cGxP, incl. data integrity
- Review and approval of analytical data / tests (analytical release)
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Support exception investigations
- Review and approval of production, QC, and AS & T records
- MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
- Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments. Preparation and participation to internal HSE audits
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements:
- Essential Requirements:
- 5+ years of experience in pharmaceutical quality control, quality assurance or production
- Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
- Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
- Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
Desirable Requirements:
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)Senior QA Operations Specialist
Division
Operations
Business Unit
Innovative Medicines
Location
Singapore
Site
Tuas South Avenue
Company / Legal Entity
SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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