Job Description

: Responsibilities * 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 pr : Responsibilities 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 Review and approve cleaning instructions and records and ensure compliance with the company's Quality Standards (PQS) and guidelines. Review and approve GMP documentation (e.g. SOPs, protocols and reports, change controls) and ensure their compliance to company's Quality Standards (PQS). Ensure adherence to quality procedures, regulatory requirements and cGMPs. Review and approve deviations according to site procedures. Handle product complaints. Ensure complaints are investigated thoroughly with effective CAPAs to prevent recurrence. Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes. Participate in gap analysis of site procedures and propose required actions to address identified gaps and mitigate risks. Conduct internal audits to ensure the internal controls are effective. Support the maintenance of validated stated of GMP systems and processes. Support regulatory submissions and attend to regulatory queries in a timely manner. Lead improvement of quality assurance systems, as necessary. Mentor junior members (including interns) within the Quality Assurance team. Actively participate in Safety initiatives, and perform investigation related to EHS (as needed). Requirements Degree in Chemistry, Microbiology, Engineering or other Science related discipline. Diploma in Science related discipline with a minimum of 10 years experience in Quality Assurance role within the medical device/ lifescience industry will be considered. Minimum 3 years experience in a Quality Assurance role within the medical device/ lifescience industry. Experience in Compliance, regulatory or validation experience is an advantage. All qualified applicants, please send in your resume to: [HIDDEN TEXT] Tricia Celestine Goh (R1981653) Recruit Express Pte Ltd Company Reg. No. 199601303W | EA License Number: 99C459 If you meet the requirements of this role, please email a detailed resume in Word document to Tricia Goh Celestine. CEI Registration No.: R1981653 Email: [HIDDEN TEXT] Tel: 67363280 .All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.