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