JOB PURPOSE- Ensure overall compliance with Company's Quality Management System encompassing the company quality policies, relevant ISO, GMP, GDP, GCP, GDPMD,clients' and customers' requirements and regulatory requirements in Zuellig Pharma Malaysia and Brunei including branches.KEY RESPONSIBILITIES- To review and manage the document control function ensuring documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner. Work within the company to improve the document control process through training another process improvements.- To maintain and monitor the progress of the CAPA system as the appointed Corrective and Preventive Actions (CAPA) Coordinator (CC)- To ensure effective implementation of CAPA responses and CAPA closure times as per regional guidelines or as per timeline required by Clients.- To maintain the CAPA tracking system and reports the progress of the CAPA to the Quality Manager (QM) and Zuellig Pharma Regional Quality Assurance (RQA) monthly.- To assist the QM in managing the CAPA system from initiation to closeout.- To assist the QM in ensuring that the CAPA system is compliant to the requirements of regional guideline, and the Clients,- To produce trends and analysis of CAPA and non-conformances for quality reviews and proposal of improvements, if necessary.- To assist the QM in external quality audits conducted including clients, regulatory body and supplier audits. To coordinate the audit responses from process owners and ensures that they are appropriate in these areas of coverage.- To assist the QM in leading / conducting self-inspections and internal audits to ensure that the Company is qualified in accordance to ISO, SOP, GSDP, GDP and GMP's requirements as well as the Zuellig Pharma's Code of Conduct.- To coordinate the audit responses from process owners and ensures that they are appropriate, timely and within the required standards. To track and follow-up till closure for the audit CAPA as per above CC role.- To conduct duties as a Quality System Internal Auditor ensuring compliance to regulations and internal standard operating procedures.- To support and coordinate on site management review and follow up actions.- To assist QM to manage the change control process to meet amendments to local regulatory compliance and internal projects.- To assist QM on maintenance of supplier files with required documentation and manager and maintain the Approve Supplier List ensuring follow-up requirements (audits) are met.- To report to QM on departmental issues, non-conformities, and accomplishments. To ensure that there is prompt and effective communication both internally and externally to keep all interested parties informed proactively. This includes but not limited to superiors, subordinates, colleagues, principals and customers.- To attend, participate, and conduct meetings including cross-functional meetings when needed. Supports and participates in cross-functional projects when assigned/appropriate.- To perform other duties as assigned when required.**REQUIREMENTS**:- At least 2 years experience in similar role- Knowledge on company operations and procedures- Knowledge on GMP, GSDP, GDPMD and ISO 9001 requirements**Salary**: RM3,000.00 - RM4,000.00 per monthSchedule:- Monday to FridayAbility to commute/relocate:- Bukit Jelutong: Reliably commute or planning to relocate before starting work (required)
