QA Officer

Responsibilities: • Quality Assurance Activities: • Develop, implement, and maintain quality assurance procedures and protocols, ensuring compliance with relevant regulations and standards. • Conduct audits, inspections, and investigations to identify and address quality issues. • Perform root cause analysis and implement corrective and preventative actions (CAPA). • Manage and maintain quality records and documentation. • Participate in the development and execution of test plans and test cases. • Identify and document quality issues, ensuring timely resolution. • Contribute to the development and implementation of quality control procedures. • First articles process buy-off, report generating and submission for customer approval. • Creating and supporting the process validation protocol (IQ, OQ, and PQ). • Develop the control plan and FMEA for the process. • Required to participate and support in the internal and external audit. Documentation and Reporting: • Prepare and maintain accurate and complete quality documentation. • Generate reports on quality performance and trends. • Participate in the review and approval of quality-related documents. Knowledge: • Knowledge of cGMP regulations and industry standards • Experience with quality management systems (e.g., ISO 9001, ISO13485). • Familiarity with various pharmaceutical product forms (e.g., tablets, capsules, injectables, urine bag, supporting Tray). • Experience with quality control testing methods and equipment. • Familiar on the techniques of fundamental process FMEA and control plan approach. • Familiar to create the manufacturing process validation protocol (IQ, OQ, PQ). • Experience on process capability CPK, PPK, Gauge R&R (Attribute and variable) and control charts. Skills: • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Ability to work independently and as part of a team. • Attention to detail and a high level of accuracy.