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 Valuable 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)
B. Pharm/M. Ph