[ref. s2643001] QA Specialists (Manufacturing/ Pharmaceutical ) - Bukit Batok
Manpower Staffing Services Bukit Batok Full-time
Responsible for activities involved in quality oversight for change control system, product change control oversight with Regulatory Affairs and APR program management. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives.
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications.
- Prepare Annual trend for deviations and Product Complaints
- Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Conduct internal audits to ensure the internal controls are effective.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
- Qualify and manage suppliers according to Quality Standards (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk
- Bachelor's Degree in Science/Chemical Engineering or equivalent.
- Experience in Quality Assurance role within the pharmaceutical industry
Veronica Neo Shen Hwa - [email protected]
Personnel Reg No: R1110855
Manpower Staffing Services (S) Pte Ltd
EA Licence No: 02C3423
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