Associate(QualityAssurance–Operations/Compliance/Investigations)

**Use Your Power for Purpose** Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements. **What You Will Achieve** Roles Responsibilities * Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging) * Document review and Good Documentation Practices * Basic knowledge of change control and risk assessment * Knowledge of chemical and microbiology testing * Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships * Acts Decisively: Makes decisions in a timely manner based on available information * Grows Self: Identifies individual development needs and works towards achieving those objectives * Critical thinking and compliance mindset * Ability to work in cross-functional teams Core Responsibilities: **Quality Operations** * Review QC documents (BQ, CQ), batch records, and related documents * Support shop-floor QA activities including GMP compliance monitoring and process checks * Perform in-process checks and support batch documentation review * Review SOPs, specifications, STPs, and study protocols **Quality Compliance** * Support audit activities, inspection readiness, and regulatory commitments * Ensure adherence to cGMP, GDP, and regulatory requirements * Support quality systems such as Change Control, CAPA tracking, and document management * Assist in data integrity and documentation control activities **Quality Investigations** * Support deviation investigations and CAPA implementation * Assist in root cause analysis using investigation tools * Track investigation closure within timelines * Ensure proper documentation of investigation records **Here Is What You Need (Minimum Requirements)