Job Description

Job Details: Position: Quality Compliance Specialist Company Sector: Healthcare Working Hours: Monday - Friday (0800 to 1700) Working Duration: 12 months contract with PERSOLKELLY WHO CAN APPLY Bachelor\'s degree in Pharmaceutical, Pharmacy or Science or equivalent Has good understanding on ISO9001:2015, ISO 13485:2016 or GDP/GDPMD Minimum 3-5 years\' experience in Quality function Certified ISO 13485 or GDPMD auditor is preferred Experience with project management is preferred Responsibilities: . Ensure implementation, monitoring and improving local Quality Management System (QMS) with regulatory compliance across the company in alignment with Healthcare Business Group corporate quality standards and country regulatory requirements . Prepare, review, update, track implement and monitor compliance of standard operating procedures . Support Quality team in deployment of corporate policy to country local QMS . Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities (including customer complaints handling and supplier/subconmanagement) . Support audit(s) activities including internal audit, external audit, supplier audit and regulatory audit . Participate in CAPA board meeting to ensure corrective and preventive action is meeting corporate and country regulatory requirements. Ensure timely follow-up, execution, completion of necessary action and review effectiveness of CAPA. . Support quality compliance improvement programs/projects . Work closely with Management team to improve internal control and governance practices to enhance the effectiveness and efficiency of the operations and process to ensure compliance . Serve as the point of the contact in the country on quality compliance matter . Conduct and support training activities to cross-functional team in the country in alignment with corporate QMS requirements . Support regional Quality Compliance leader to drive and implement any improvement project in country . Issue CAPA based on audit findings and follow up through until closure . Ensure CAPA effectiveness . Conduct and support activity related to Field Corrective Action (FCA). Ensure timely follow-up, execution and completion of necessary action . Plan and conduct audit(s) on subcon activity regularly to ensure effectiveness of QMS . Identify requirements and establish the process for Issue Review and Escalation to division . Leads the Identify and Assess steps within the Issue Review portion of this process. Responsible for documentation and obtaining approvals of the Issue Review Document . Responsible for the investigation in issue review Serious applicants may send your resume to [HIDDEN TEXT] Only qualified candidates will be contacted for interview. We thank you for your application.

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