Key Job Purpose:
- Manage Post Market Surveillance activities (FCA, Recall, FSCA, AE) in the APAC region, ensuring compliance with laws, regulations, and quality standards.
- Support QMS audits in APAC (ISO 9001, 13485, 14001) related to FSCA/FCA compliance.
- Oversee QM/QA aspects in design changes, change requests, and CSV (Computer System Validation) documentation for software and hardware.
- Ensure CSV processes comply with company QMS, cGMP, GAMP, ER/ES, and other relevant standards/regulations.
- Act as Regional Subject Matter Expert (SME) for post-market activities and CSV provide guidance to affiliates.
- Serve as QM representative in ISO 27001:2022 Information Security Management System (ISMS) project:
Support implementation and certification efforts.
Assist in scope expansion based on business direction.
Maintain ongoing ISO 27001:2022 compliance.
Job Description:
- Ensure the establishment and maintenance of SAP's QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
- Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
- Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within organization affiliates and business partners and manufacturers.
- Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
- Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
- Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
- Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
- Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
- Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
- Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
- Execute any tasks given by supervisor or SAP's management.
Job Requirements :
- Bachelor's Degree in Engineering or Science
- 5 years of Quality Management experience in Medical Device industry.
- 3 years of CSV documentation & processes validation.
- Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
- Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
- Good understanding of computer systems / software used in various companies in the medical industry.
HOW TO APPLY
Interested applicants, kindly click on APPLY NOW or send your resume in MS WORD format to hestia.wong(at)trustrecruit.com.sg
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