By Agon Consulting | July 2025
For new hires, students, and professionals entering pharmaceutical Quality Assurance (QA)
Welcome to QA — One of the Most Important Roles in Pharma
Starting a role in pharmaceutical Quality Assurance (QA) is more than a career move — it’s a step into a field where your attention to detail could directly impact patient safety.
Whether you’re a fresh graduate, transitioning from another department, or stepping into a GMP-compliant facility for the first time, this is your opportunity to learn how the pharma world truly works—and where you fit in.
The truth is QA can feel intimidating at first. There are endless acronyms, strict documentation rules, and what feels like a constant stream of audits, trainings, and reviews. But don’t worry—you’re not expected to know it all at once. In fact, your first 30 days are all about building foundations, asking questions, and adopting a mindset of vigilance and integrity.
Why QA Matters: It’s More Than Just Checking Boxes
In pharmaceutical manufacturing, quality assurance is the system of systems. It’s not a department that fixes mistakes—it’s the discipline that prevents them. QA governs the way medicines are designed, produced, packaged, tested, and released.
As a QA professional, your job is to
- Ensure processes meet GMP requirements
- Investigate deviations and implement corrective actions
- Maintain accurate, real-time documentation
- Protect product integrity and patient safety at every step
In conclusion, your work helps ensure that patients receive medicines that are safe, effective, and manufactured consistently—every time.
Your First 30 Days: A Week-by-Week Guide
This onboarding roadmap is structured around 4 key themes — Foundations, Documentation, Observation, and Participation. Use it as your personal 30-day learning plan.
Week 1: Understand the Foundations
Your Goal: Build a solid understanding of GMP principles, regulatory expectations, and your site’s quality system.
Key Documents to Review:
- Site Master File (SMF): Overview of your site’s operations, facilities, personnel, and quality system.
- Quality Manual: Describes your company’s commitment to quality and how GMP is implemented.
- Core SOPs: Understand how procedures are structured, approved, and controlled.
Essential Terms to Learn:
- **Deviation—**Any unplanned event that departs from approved instructions.
- **CAPA—**Corrective and Preventive Actions taken after deviations or audits.
- OOS (Out of Specification)—Lab or product test result that falls outside predefined limits.
- **Change Control—**A formal process for managing changes to systems, equipment, or documents.
- **Batch Record—**A complete, traceable record of a product’s manufacturing process.
Action Steps:
- Shadow a QA colleague during daily walk-throughs or inspections
- Request a guided facility tour — understand the material and personnel flow
- Attend GMP onboarding sessions or training modules
Pro Tip:
Start a QA notebook. Log questions, acronyms, insights, and examples you encounter. This will become your personal GMP reference.
Week 2: Master Documentation and Data Integrity
Your Goal: Understand how documentation works, why it’s critical, and how to spot errors and gaps before they become problems.
Focus Areas:
- GDP (Good Documentation Practices): Everything must be clear, accurate, and timely.
- Batch Manufacturing Records (BMR): Learn how these are structured and reviewed.
- Logbooks, Forms, and Labels: Understand how to complete, check, and file them correctly.
- Audit Trails: Especially for digital systems (e.g., LIMS, MES, or eQMS)
Learn the ALCOA+ Principles:
These are the pillars of data integrity:
- Attributable: Who did it?
- Legible: Can it be read?
- Contemporaneous: Was it recorded in real time?
- Original: Is it the first record?
- Accurate: Is it correct and verified?
And the “+”:
- Complete, Consistent, Enduring, Available
Common Mistakes to Avoid:
- Backdating
- Leaving blank fields
- Using correction fluid
- Recording data outside validated systems
Action Steps:
- Review recent deviation reports and BMRs with your supervisor
- Practice documenting mock scenarios (log entries, label fills, etc.)
- Ask to observe how QA reviews documents before batch release
Pro Tip:
Every signature, timestamp, and initial tells a story. If documentation isn’t clean, regulators may assume the process wasn’t either.
Week 3: Observe Processes & Ask Smart Questions
Your Goal: Move from passive learning to active observation. Start seeing how QA decisions play out on the production floor and in the lab.
Where to Focus:
- Production Floor: Observe gowning, material transfers, and batch execution
- Environmental Monitoring (EM): Learn how cleanroom conditions are recorded and interpreted
- Cleaning & Sanitization Logs: Verify if records match the actual state of equipment
- Equipment Logs & Calibration Records: Understand how traceability is maintained
Learn QA vs QC:
- QA: Process-oriented, preventive, system-level oversight
- QC: Lab-based, analytical, focused on finished product and raw material testing
Sample Questions to Ask:
- “What’s the most common deviation in this process?”
- “How do we verify that a cleaning step was effective?”
- “What happens if a label is misplaced?”
- “Who decides when a batch can be released?”
Action Steps:
- Join internal training sessions or mock audits
- Observe a deviation triage meeting (if permitted)
- Compare SOPs with how tasks are actually performed
Pro Tip:
The best QA professionals aren’t there to catch people — they’re there to understand systems. Speak with empathy and curiosity.
Week 4: Get Involved in the QA System
Your Goal: Start actively contributing — even in small ways. This is your time to participate in real QA activities under supervision.
Activities to Join:
- Deviation Investigations: Help gather information or write draft reports
- CAPA Assessments: Learn how root cause analysis is performed
- Batch Record Reviews: Check completeness, sequence, and signatures
- GMP Training Sessions: Help take attendance or prepare materials
- Supplier Audits / Qualification Meetings: Observe how external partners are vetted
Build Your QA Notebook:
- Note every acronym, system, or tool you hear but don’t fully understand
- Track your learning goals for the next 60–90 days
- Begin mapping your interests — compliance, validation, documentation, training, etc.
Pro Tip:
Find a mentor. Ask a senior QA associate for regular 10-minute check-ins. They’ve likely seen it all — and can fast-track your learning.
Bonus Resource: Free GMP Cheat Sheet (PDF)
Need a quick reference for your desk or lab coat?
- Key QA terms
- ALCOA+ principles
- GDP do’s and don’ts
- First-week priorities
