Senior/ QA Specialist (Batch Release / API) - Bukit Batok

• To provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards and guidelines
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work to file products and address regulatory queries in an accurate and timely manner.
• Mentor members within the Quality Assurance team
• 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.
• Review QC lab worksheets for intermediates, APIs and cleaning samples.
• Disposition of the intermediates and active pharmaceutical ingredients (API), including re-evaluation.
• Review and approve cleaning records and procedures and ensure compliance with the Quality Standards and guidelines.
• Support production startup activities including new product introduction (NPI), changeover activities, equipment releases, module clearance etc.
• Tank farm monitoring and QA oversight of the solvent recovery processes.
• Review and approve GMP documentation and ensure their compliance
• Ensure adherence to quality procedures, regulatory requirements and cGMPs
• Perform Quality Impact assessment for Change control.
• Act as label administrator and manage Category 1 manual labels according to stipulated procedure.
• Perform quality review of material master data setup in SAP and create label template for intermediates and APIs.
• Coordinate with cross-functional team to prepare Annual Product Record Review, discuss trends and atypical observations and recommend improvement actions.
• Support and facilitate product return process.
• Support internal audits to ensure the internal controls are effective.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walkdowns to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Support regulatory queries in a timely manner, eg regulatory COA issuance.
• QA oversight of site processes and systems e.g. pest control program, warehouse and engineering (calibration and preventive maintenance).
• Continuous improvement on quality processes and practices on site .
• Bachelor Degree/Diploma in Science/Chemical Engineering or equivalent

Veronica Neo Shen Hwa - [email protected]

Personnel Reg No: R1110855

Manpower Staffing Services (S) Pte Ltd

EA Licence No: 02C3423