Salary: up to $4000
Working Days & Hours: Mon-Fri Office Hours
Location: Redhill
Job Description:
Perform review and release of materials, including therapeutic products intended for clinical trials and packaging components.
Provide support on Quality matters to Project Management / Operations in the area of clinical packaging, storage and distribution.
Evaluate CAPA effectiveness and identify process improvements.
Review and approval of Change Control, Complaints, and Deviation reports.
Monitor closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations.
Manage site SOP System, including review, update and approval of SOPs.
Approve specifications, sampling instructions and other Quality Control procedures.
Review and approval of validation/ qualification documents.
Perform the role of a System Administrator for Quality-related Computerized Systems.
Perform in-process checks during secondary assembly/ packaging activities and inspection of incoming materials, as required.
Authorized Person Responsibility:
Perform review and approval of batch records (pre-execution and post-execution) to ensure compliance with applicable regulations and guidelines.
Perform batch certification in accordance with the principles detailed in Annex 16 of the PIC/S GMP Guide, and any other applicable guidelines or regulations.
Perform release of Finished Goods (after secondary assembly/ packaging activities).
Audits:
Coordinate client audits and regulatory inspections.
Ensure timely consolidation and provision of response reports for client audits and regulatory inspections.
Perform supplier qualification, including audit of external suppliers and contractors.
Maintain external/internal audit observation database and track observation response through to closure including a review of the corrective actions taken.
Schedule and perform internal audits as per audit plan.
Job Requirements: Min Degree in Sciences or similar w min 3 yrs of relevant QA experience in pharmaceutical industry
Interested candidates, please submit your resume to: [email protected]
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
