Position Title: Quality Assurance Executive (Quality Compliance)
Workbase: Cheng, Melaka
Duties and Responsibilities:
1.Source Quality Management (SQM):
- Vendor management: Ensure effective control and qualification of raw materials and packaging materials from approved sources. Review and maintain supplier quality agreements and monitor supplier performance. Support in the evaluation and re-evaluation of suppliers based on risk and compliance.
- Artwork management: Coordinate with stakeholders and vendors on revision and approval of the artworks. Control of approved artwork in relevant e-systems for the implementation. Ensure artwork changes are reflected in the correct version of packaging instructions and that obsolete versions are archived.
- Contract Manufacturing Product: Perform quality review of documentation related to contract-manufactured products. Ensure timely and compliant release of contract-manufactured goods. Coordinate with contract manufacturers on quality complaint, investigation and CAPA closure.
- Finished Good Return Management: Manage the process of returned finished products including evaluation, investigation, and final disposition. Maintain documentation of returned goods in accordance with GMP and company procedures.
2.In-process Quality Assurance: Responsible to act as the first line of quality oversight during production activities at the shopfloor meets regulatory requirements ensuring product quality and data integrity.
- To ensure real-time monitoring, verification and control of manufacturing and packaging processes in compliance with Good Manufacturing Practice (GMP), company SOPs, regulatory standards and ALCOA+ compliance.
- To perform investigation related to IPQA testing out-of-specification.
- To prepare Validation Master Plan for IPQA equipment and execute the qualification as planned. To qualify IPQA testing equipment and software system to ensure reproducibility of accurate results. To track and monitor all machinery in GMP floor meet the validity status for use.
- To coordinate with production for sampling activities according to sampling plan indexed by Acceptance Quality Limit (AQL). To coordinate and verify reprocessing and re-inspection activities with sampling inspection.
- Environment monitoring: Conduct and monitor routine environmental sampling for cleanliness and microbial control. Evaluate trends and escalate issues for investigation as needed.
3.Document Management:
- Document Management System: Responsible as the system custodian and maintain its use within the organization. Initiate improvements where necessary. To provide technical support to the users as and when necessary.
- Document center management: Oversee control, issuance, archiving, and retrieval of controlled documents. Ensure documentation is current, properly authorized, and meets regulatory requirements.
- Batch manufacturing record management: Coordinate the issuance, reconciliation, and review of Batch Manufacturing Records for accuracy and completeness in conjunction to change, deviation, reprocessing/ re-inspection, new products, revision, format update etc. Ensure BMRs are in compliance with Master Manufacturing Formula and regulatory standards.
- Master manufacturing formula and packaging instruction: Maintain and update master formulas and packaging instructions. Ensure documents reflect current manufacturing practices and regulatory requirements. Prepare and upkeep the documents to ensure alignment with regulatory filings, validated processes, and internal quality standards by coordinating with relevant stake-holders during the revision. Maintain and ensure traceability of approved versions in compliance with the document control system.
- Robust Weighing System: Ensure update related to formulation is updated in the Robust Weighing System for all relevant production blocks.
- E-Packaging System and Info-tag management: Coordinate on the issuance of controlled artwork used in both E-Packaging System and QR Code System for info-tag. Ensure output correctness as indicated in artwork management system.
- Reprocessing: Prepare reprocessing BMR. Support the evaluation and documentation of reprocessing activities. Ensure any reprocessing is justified, validated, and properly approved.
4.Retained sample management: Ensure proper storage, labelling and disposal of retained samples. Maintain traceability and compliance with regulatory retention requirements.
5.Training management: Coordinate and monitor the execution of quality-related training programs for all personnel. Ensure training records are updated and reflect current competency status.
6.Integrated Pest Management (IPM): Monitor and maintain the Integrated Pest Management program across the facility, ensuring its alignment with GMP and safety standards. Review pest control reports and coordinate corrective/preventive actions with relevant departments and pest control service providers. Coordinate the pest trending review accordingly.
Minimum Requirements:
1.Preferably Degree in Pharmacy, Chemistry, Microbiology, Science or Engineering, with minimum two years (QA Executive II) and three years (QA Executive I) working experience in the quality assurance, quality control or related functions in a manufacturing operation.
2.Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
3.Good knowledge of ISO and PIC/S regulations and cGMP is required.
4.Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
5.Attention to detail, possess planning and organizing skills, judgment skills and decision-making skills.
6.Proficient in Microsoft Office applications.
