QA Team Member (QMS & Validation)

ACG Capsules (Thailand) (Rayong)

Rayong, Thailand

ACG is the world’s only integrated pharma manufacturing solutions company. Capsules + Films & Foils + Engineering + Inspection and Track & Trace systems, we do it all. Your global partners for end-to-end pharmaceutical solutions, no matter where you are. ACG Worldwide has a presence in over 100 countries with its products and services, employing more than 3,200 members that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems. With over 20,000 machine installations worldwide, it speaks lengths of the high quality standards we follow at ACG as well as complying with major international quality certifications or legislation's.

About this position

ACG Capsules (Thailand) Co., Ltd. is seeking a QA Team Member for QMS & Validation to ensure compliance with quality management systems and regulatory requirements.

Responsibilities

• To ensure the Plant complies to the QMS system as per the laid down guidelines.
• Review of production schedule and their compliance to the specific requirements in the manufacturing of products.
• Ensure correct and timely issuance of batch documents.
• Ensure traceability and reconciliation of All documents and review the same for non-compliance.
• Destruction of documents after its expiry period with proper record.
• Ensure all the Quality Assurance documents are filled completely.
• To ensure effective implementation of DMS system in all departments.
• Support to QA Manager during the internal and external audits.
• Support to QA manager by carry out self-inspection / CTQ audits.
• To carry out inspection of Transit vehicle.
• Working with the Engineering Team / Calibration team with compliance with GEFU.
• Handling of DMS system.
• To perform customer complaints handling as per procedure.
• Monitoring of CAPA.
• Maintaining, preparing & review of monthly QMS reports.
• Adherence to Regulatory Compliance.
• Compliance to GMP Audit/Process Audit.
• Ensure c-GMP compliance during the entire manufacturing process.
• Timely updating QMS documents to keep all in line with regulatory requirements.
• Compliance during Internal, external & Regulatory audits.
• Improve document control across plant.
• To ensure training of all associates on QMS.

Requirements

• Bachelor or degree in Chemistry or related to.
• Experience in Pharmaceutical / Healthcare / Beverage / Food Processing industry at least 2 years.
• Incharge of 2 areas for QMS system (DC, Audit) and Validation.
• English Communicable.
• Willing relocate to Rayong Province (WHA Rayong Industrial Land).